5,819 Clinical Project jobs in the United Kingdom

Clinical Project Manager

London, London Green Life Science

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Job Description

Job Title: Contract Clinical Project Manager

Location: South East, UK (Hybrid/Flexible Working Options)

About Us

We are a dynamic, mid-sized Clinical Research Organisation (CRO) with a strong reputation for delivering high-quality clinical trial services across Europe and beyond. With a focus on cutting-edge oncology and radiopharmaceutical studies, we support biotech and pharmaceutical clients in bringing innovative treatments to patients faster.

As our project portfolio continues to expand, we are seeking an experienced Contract Clinical Project Manager to join our growing team on a contract basis.


Role Overview

As a Clinical Project Manager , you will lead and manage multiple clinical trials from start-up through to close-out, ensuring timelines, budgets, and quality standards are met. You will serve as the primary point of contact for both internal teams and external sponsors, driving operational excellence and strategic execution.


Key Responsibilities

  • Lead cross-functional project teams across global Phase I–III clinical trials
  • Serve as the primary sponsor contact for project updates, timelines, and deliverables
  • Oversee site selection, study start-up, patient recruitment, and monitoring activities
  • Ensure compliance with ICH-GCP, regulatory requirements, and internal SOPs
  • Manage budgets, timelines, and risk mitigation plans
  • Facilitate internal and external meetings and ensure robust documentation
  • Mentor junior project team members and foster a culture of collaboration


Essential Experience

Previous CRO experience is mandatory

Proven experience working as a contract Clinical Project Manager

Strong background in oncology , specifically

  • Demonstrated ability to lead multi-country studies
  • Excellent communication and vendor management skills
  • Strong understanding of clinical trial lifecycle and ICH-GCP guidelines


Preferred Attributes

  • Based in or easily commutable to the South East UK (hybrid flexibility available)
  • Adaptable and able to thrive in a fast-paced, matrix environment
  • Proactive, solutions-oriented mindset
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Clinical Project Manager

Green Life Science

Posted today

Job Viewed

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Job Description

Job Title: Contract Clinical Project Manager

Location: South East, UK (Hybrid/Flexible Working Options)

About Us

We are a dynamic, mid-sized Clinical Research Organisation (CRO) with a strong reputation for delivering high-quality clinical trial services across Europe and beyond. With a focus on cutting-edge oncology and radiopharmaceutical studies, we support biotech and pharmaceutical clients in bringing innovative treatments to patients faster.

As our project portfolio continues to expand, we are seeking an experienced Contract Clinical Project Manager to join our growing team on a contract basis.


Role Overview

As a Clinical Project Manager , you will lead and manage multiple clinical trials from start-up through to close-out, ensuring timelines, budgets, and quality standards are met. You will serve as the primary point of contact for both internal teams and external sponsors, driving operational excellence and strategic execution.


Key Responsibilities

  • Lead cross-functional project teams across global Phase I–III clinical trials
  • Serve as the primary sponsor contact for project updates, timelines, and deliverables
  • Oversee site selection, study start-up, patient recruitment, and monitoring activities
  • Ensure compliance with ICH-GCP, regulatory requirements, and internal SOPs
  • Manage budgets, timelines, and risk mitigation plans
  • Facilitate internal and external meetings and ensure robust documentation
  • Mentor junior project team members and foster a culture of collaboration


Essential Experience

Previous CRO experience is mandatory

Proven experience working as a contract Clinical Project Manager

Strong background in oncology , specifically

  • Demonstrated ability to lead multi-country studies
  • Excellent communication and vendor management skills
  • Strong understanding of clinical trial lifecycle and ICH-GCP guidelines


Preferred Attributes

  • Based in or easily commutable to the South East UK (hybrid flexibility available)
  • Adaptable and able to thrive in a fast-paced, matrix environment
  • Proactive, solutions-oriented mindset
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Clinical Project Manager

Scout

Posted today

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Job Description

Established in 1996 and rebranded to Scout in 2024, we built our foundation on planning meetings for numerous organizations within the life sciences sector (Scout Meetings). In response to emerging industry needs, we expanded our services to include Scout Clinical, one of the top providers of clinical trial patient travel and reimbursements, and Scout Academy, our secure, online, on-demand learning management system that ensures global compliance.


Scout is recognized as a leader in our field for innovation in service, attention to detail, our stellar team members, and making the complex easier. If this interests you, we’d love to have you join our rapidly growing team!


Position Summary:

We are looking to hire a talented and eager Clinical Project Manager to join our UK team in a remote position. The Project Manager will perform a wide variety of activities to support the start-up, management, and completion of patient services for clinical research studies.


Responsibilities of this position include but are not limited to:

Contracts support

  • Review protocols in support of new requests for proposal or assigned projects


Study management activities and study start-up

  • Maintain required study tracking database to accurately reflect the status of the studies and deliverables
  • Regular communication with global study stakeholders including CRO and Sponsors. Managing client expectations and escalations.
  • Schedule and lead study, Kick of Meetings, Investigators’ Meetings, and follow-up calls
  • Act as main point of contact to Sponsor and CRO clients for Scout Clinical services for assigned studies
  • Collaborate on operational internal policies and manage adherence
  • Oversee regulatory onboarding process of studies in collaboration with Scout Clinical Compliance Team
  • Manage preparation of study-specific patient and site-facing documentation throughout the life of the study
  • Manage training of sites, and study teams on utilization of the Scout portal as needed
  • Oversee and manage Scout Clinical portal configuration for assigned studies
  • Work with Patient Liaison team to support travel and reimbursement activities associated with assigned studies
  • Review and manage study utilization and financial metrics.


The ideal candidate will have the following experience, skills, and knowledge:

  • Bachelor’s Degree or equivalent experience
  • Experience in the clinical/healthcare industry, preferably clinical research
  • Strong understanding of project management
  • Strong understanding of the clinical trial process and clinical trial protocols
  • Ability to handle multiple projects in various planning stages concurrently
  • Ability to track and manage key dates/deadlines


The ideal candidate will have the following competencies and qualities:

  • The desire to learn/be coachable
  • Timely, professional, courteous communication with clients, vendors and colleagues
  • Attention to detail
  • Well organized with an ability to prioritize and multi-task
  • Ability to work within and meet strict deadlines
  • Ability to work under pressure in a fast paced, demanding environment
  • Forward thinking / problem solver / critical thinker / analytical
  • Team player


Visit our website at or follow us on LinkedIn for other employment opportunities.


WE ARE AN EQUAL OPPORTUNITY EMPLOYER

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Clinical Project Coordinator

London, London £300 - £360 Daily SRG

Posted 9 days ago

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Job Description

temporary

Clinical Project Coordinator
Job Type: Temporary
Location: London/Remote
Contract Length: 12 months
Rate: circa. 350 per day

SRG are collaborating with a global Pharmaceutical Company who have a new opening for a Clinical Project Coordinator to support the team for a 12 month contract. This role has been designed to be in support of the Clinical Development excellence team. This will include providing project management support such as planning and conducting meetings and ensuring operational tasks within the group are performed to regulatory and quality standards.

Main Responsibilities may include:

  • Leads and/or facilitates activities to support project or process lead in the successful execution of the project/process
  • Schedules and prepares project meetings and workshops according to meeting excellence (including logistics, agenda, minutes, action items)
  • Handles inquiries from stakeholders as a first contact, monitors against deliverables of various stakeholders, flags issues, opportunities and solutions to project/process lead
  • Captures and reports project/process metrics
  • Maintains associated SharePoint sites, monitors needs to adapt content; independently drives agreement process with respective members and continuously updates
  • Maintains network information, calendars & schedules, mailboxes, FAQ documentation

Skills/experience required:

  • Bachelor or Master degree in science or business related studies
  • Associate degree or equivalent required if accompanied by 2 years Drug Development experience
  • Proven track record in project management skills
  • Familiar with the Drug Development process
  • Able to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude
  • Ability to simplify processes while delivering on given objectives
  • Strong analytical and data driven mind-set
  • Action orientated mindset: make things happen - exhibit a strong will to drive change
  • Ability to work independently without much direction and guidance
  • Strong interpersonal, communication (written and verbal) and negotiation skills

To Apply:

If you want to find out more about this role or would like to make an application, please click to apply and/or email me: to discuss in more detail.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

This advertiser has chosen not to accept applicants from your region.

Clinical Project Coordinator

EC1 London, London SRG

Posted 1 day ago

Job Viewed

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Job Description

temporary

Clinical Project Coordinator
Job Type: Temporary
Location: London/Remote
Contract Length: 12 months
Rate: circa. 350 per day

SRG are collaborating with a global Pharmaceutical Company who have a new opening for a Clinical Project Coordinator to support the team for a 12 month contract. This role has been designed to be in support of the Clinical Development excellence team. This will include providing project management support such as planning and conducting meetings and ensuring operational tasks within the group are performed to regulatory and quality standards.

Main Responsibilities may include:

  • Leads and/or facilitates activities to support project or process lead in the successful execution of the project/process
  • Schedules and prepares project meetings and workshops according to meeting excellence (including logistics, agenda, minutes, action items)
  • Handles inquiries from stakeholders as a first contact, monitors against deliverables of various stakeholders, flags issues, opportunities and solutions to project/process lead
  • Captures and reports project/process metrics
  • Maintains associated SharePoint sites, monitors needs to adapt content; independently drives agreement process with respective members and continuously updates
  • Maintains network information, calendars & schedules, mailboxes, FAQ documentation

Skills/experience required:

  • Bachelor or Master degree in science or business related studies
  • Associate degree or equivalent required if accompanied by 2 years Drug Development experience
  • Proven track record in project management skills
  • Familiar with the Drug Development process
  • Able to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude
  • Ability to simplify processes while delivering on given objectives
  • Strong analytical and data driven mind-set
  • Action orientated mindset: make things happen - exhibit a strong will to drive change
  • Ability to work independently without much direction and guidance
  • Strong interpersonal, communication (written and verbal) and negotiation skills

To Apply:

If you want to find out more about this role or would like to make an application, please click to apply and/or email me: to discuss in more detail.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

This advertiser has chosen not to accept applicants from your region.

Clinical Project Lead

Witney, South East Abbott

Posted 24 days ago

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Job Description

**About Us:** At Abbott, we help people live more fully at all stages of life. Abbott is about the power of health. For more than 130 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
Abbott Diabetes Care designs, develops, and manufactures leading-edge glucose monitoring technology for use in both home and hospital settings, including our revolutionary Freestyle Libre Flash Glucose Monitoring System.
**About the Role:**
As a **Clinical Project Lead** within Abbott Diabetes Care's Clinical Affairs team, you will play a pivotal role in driving the success of our clinical programs.
**Responsibilities:**
As a **Clinical Project Lead** within Abbott Diabetes Care's Clinical Affairs function, you will:
+ Lead cross-functional project teams in the planning, execution, and close-out of clinical trials.
+ Ensure clinical support is aligned with the needs of R&D, Marketing, Operations, Quality Assurance, and Regulatory Affairs.
+ Develop and implement strategic plans for clinical study delivery using both internal and external resources.
+ Manage relationships with clinicians, CROs, Key Opinion Leaders (KOLs), and other stakeholders to ensure successful project outcomes.
+ Serve as the primary point of contact for internal updates, issue resolution, financial reconciliation, and project timeline tracking.
+ Collaborate with internal teams including Data Management, Regulatory, Statistics, and Scientific Affairs to ensure seamless project execution.
+ Contribute to the evaluation of new or modified Abbott Diabetes Care and competitor products through clinical studies.
+ Maintain focus on key milestones, stakeholder engagement, and compliance with regulatory and quality standards.
**Education and Experience**
+ A degree in Life Sciences or a related field is preferred; however, candidates with strong relevant experience and alternative educational backgrounds will also be considered.
+ Experience in the medical device or in vitro diagnostics (IVD) industry is highly desirable; pharmaceutical experience may also be considered.
+ Proven background in clinical project management or study leadership, ideally within a regulated environment.
+ Strong communication, time management, and problem-solving skills.
+ Ability to thrive in a fast-paced, collaborative environment.
+ Willingness to travel up to 10%, with the remainder of the time based at our Manufacturing Centre of Excellence and R&D facility in Witney, Oxfordshire.
**What We Offer**
At Abbott, we believe in helping you bring your passion, ideas, and purpose to life. In return, we offer:
+ A competitive salary and benefits package.
+ A class-leading defined contribution pension scheme.
+ Share ownership opportunities.
+ A supportive and inclusive work environment that encourages career growth and development.
+ Access to a wide range of wellness initiatives and employee engagement activities:
+ At our Witney site: onsite allotments, couch-to-5k campaigns, beekeeping, yoga, and more.
Join us and shape your career as you help shape the future of healthcare.
Connect with us at or on LinkedIn at on Facebook at and on Twitter @AbbottNews.
Abbott is an equal opportunities employer.
#LI-SO2
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
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Clinical Project Manager - Sponsor Dedicated

Reading, South East IQVIA

Posted 11 days ago

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Job Description

The Senior Clinical Trial Manager will be responsible for managing clinical trial sites from study startup throughout the course of the clinical trials until site close out. They will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. They will work collaboratively with the Sponsor Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other Sponsor functional departments (as required) to drive start-up and ongoing oversight of clinical studies. They may have direct reports of Clinical Trial Managers across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality.
Responsabilities:
+ Participate in the planning, implementation and management of sponsor clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable sponsor controlled documents.
+ Oversee the site management of CROs and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time.
+ Track site visit and trip report metrics; data quality concerns and site level trending of protocol deviations.
+ Conduct oversight site visits including pharmacy visits, as required, to evaluate site and CRA performance and ensure adherence to study protocols, study operation plans, ICH GCP and regulatory requirements
+ Attend and assist, as required, at Initiation visits to confirm site training of therapeutic indication(s) and associated study procedures (e.g. Pharmacy training) and help build and foster sponsor-CRO-Investigator - site relationships
+ Review a percentage of CRA monitoring trip reports, ensuring oversight of CRO CRA and Site compliance with protocol, study plans, SOPs and ICH and GCPs, escalate identified report issues and ensure CRO study team resolve identified concerns - Collaborate with sponsor CPM and sponsor Medical Monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met.
+ Manage study start up in collaboration with internal and external project teams (e.g. sponsor Project Manager, Regulatory, Clinical Supplies, Third Party Vendors, CRO) to ensure start up timelines are clearly defined and implemented, working to identify any risks and resolving any issues.
+ Act as subject matter expert for assigned protocols for study related issues, protocol and clinical operational queries arising from CRO, IRB/IECs/RAs, Third Party Vendors and sites.
+ Provide routine updates to the internal project team on study status/issues
+ Manages the CRO/clinical trial site during start-up activities including, but not limited to, budget and contract negotiations, IRB/EC submissions and response and facilitation of essential document collection
+ Provide direction and support to the CPM in ensuring consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate.
+ Manages consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate
+ Works cross-functionally with other sponsor departments (Clinical Supplies, Quality Assurance, Regulatory Affairs) to ensure all clinical trial activities performed by sponsor as a Sponsor are performed according to study requirements and timelines.
+ Contribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, protocol, informed consent documents (master and/or site specific), budgets, monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals, case report form development and training materials
+ Execute and/or deliver trial specific training as required
+ Review of open action items and data trends; working with CROs to escalate and resolve identified issues to ensure standards for monitoring and reporting are met as well as to ensure better efficiencies and execution of our studies
+ Contribute to the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
+ Support study team with site selection while optimizing start-up processes to ensure efficient start-up timelines are met. Attend and present at Investigator Meetings on Clinical Operations topics, as required
+ May oversee the accurate, timely, and complete tracking of laboratory samples
+ May represent Clinical Operations in cross-functional initiatives (e.g., start-up, continued process improvements with CROs).
+ Contribute to the development and/or participate in the review of sponsor SOPs, Work Instructions and team policies
+ Contribute to preparation of investigator newsletters or email newsflashes.
+ Supports the internal and external project teams with audits/inspection readiness and activities, resolution of audit/inspection findings and contribution to CAPAs as required
+ Oversight of direct report(s) study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriate
+ Accountable for ensuring all study deliverables and milestones are met with quality and within timelines
+ Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets
+ Provides support/escalation point for direct reports as needed
Profile:
+ At least 8 years of relevant clinical operational experience in a biotechnology/pharmaceutical company, and/or CRO
+ Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus
+ Experience with start-up and initiation of clinical trial sites
+ Experience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required
+ Ability to communicate and coordinate activities with the internal team, clinical sites and vendors
+ Proactively identify project challenges/risks and appropriate corrective actions to the internal study teams and work with internal team, clinical sites and vendors on resolutions with minimal supervision
+ Ability to work independently
+ Experience presenting high level presentations, both orally and in writing
+ Knowledge of and experience with immunotherapies and/or Oncology
+ At least 2 years of on-site monitoring experience
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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Clinical Project Manager - Sponsor Dedicated

RG1 Reading, South East IQVIA

Posted today

Job Viewed

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Job Description

The Senior Clinical Trial Manager will be responsible for managing clinical trial sites from study startup throughout the course of the clinical trials until site close out. They will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. They will work collaboratively with the Sponsor Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other Sponsor functional departments (as required) to drive start-up and ongoing oversight of clinical studies. They may have direct reports of Clinical Trial Managers across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality.

Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below.nResponsabilities:nParticipate in the planning, implementation and management of sponsor clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable sponsor controlled documents.nOversee the site management of CROs and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time.nTrack site visit and trip report metrics; data quality concerns and site level trending of protocol deviations.nConduct oversight site visits including pharmacy visits, as required, to evaluate site and CRA performance and ensure adherence to study protocols, study operation plans, ICH GCP and regulatory requirementsnAttend and assist, as required, at Initiation visits to confirm site training of therapeutic indication(s) and associated study procedures (e.g. Pharmacy training) and help build and foster sponsor-CRO-Investigator - site relationshipsnReview a percentage of CRA monitoring trip reports, ensuring oversight of CRO CRA and Site compliance with protocol, study plans, SOPs and ICH and GCPs, escalate identified report issues and ensure CRO study team resolve identified concerns • Collaborate with sponsor CPM and sponsor Medical Monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met.nManage study start up in collaboration with internal and external project teams (e.g. sponsor Project Manager, Regulatory, Clinical Supplies, Third Party Vendors, CRO) to ensure start up timelines are clearly defined and implemented, working to identify any risks and resolving any issues.nAct as subject matter expert for assigned protocols for study related issues, protocol and clinical operational queries arising from CRO, IRB/IECs/RAs, Third Party Vendors and sites.nProvide routine updates to the internal project team on study status/issuesnManages the CRO/clinical trial site during start-up activities including, but not limited to, budget and contract negotiations, IRB/EC submissions and response and facilitation of essential document collectionnProvide direction and support to the CPM in ensuring consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate.nManages consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriatenWorks cross-functionally with other sponsor departments (Clinical Supplies, Quality Assurance, Regulatory Affairs) to ensure all clinical trial activities performed by sponsor as a Sponsor are performed according to study requirements and timelines.nContribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, protocol, informed consent documents (master and/or site specific), budgets, monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals, case report form development and training materialsnExecute and/or deliver trial specific training as requirednReview of open action items and data trends; working with CROs to escalate and resolve identified issues to ensure standards for monitoring and reporting are met as well as to ensure better efficiencies and execution of our studiesnContribute to the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plannSupport study team with site selection while optimizing start-up processes to ensure efficient start-up timelines are met. Attend and present at Investigator Meetings on Clinical Operations topics, as requirednMay oversee the accurate, timely, and complete tracking of laboratory samplesnMay represent Clinical Operations in cross-functional initiatives (e.g., start-up, continued process improvements with CROs).nContribute to the development and/or participate in the review of sponsor SOPs, Work Instructions and team policiesnContribute to preparation of investigator newsletters or email newsflashes.nSupports the internal and external project teams with audits/inspection readiness and activities, resolution of audit/inspection findings and contribution to CAPAs as requirednOversight of direct report(s) study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriatenAccountable for ensuring all study deliverables and milestones are met with quality and within timelinesnProvide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assetsnProvides support/escalation point for direct reports as needednProfile:nAt least 8 years of relevant clinical operational experience in a biotechnology/pharmaceutical company, and/or CROnWorking knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plusnExperience with start-up and initiation of clinical trial sitesnExperience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where requirednAbility to communicate and coordinate activities with the internal team, clinical sites and vendorsnProactively identify project challenges/risks and appropriate corrective actions to the internal study teams and work with internal team, clinical sites and vendors on resolutions with minimal supervisionnAbility to work independentlynExperience presenting high level presentations, both orally and in writingnKnowledge of and experience with immunotherapies and/or OncologynAt least 2 years of on-site monitoring experiencenIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
This advertiser has chosen not to accept applicants from your region.

Clinical Project Manager - Sponsor Dedicated

RG1 Reading, South East IQVIA

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

The Senior Clinical Trial Manager will be responsible for managing clinical trial sites from study startup throughout the course of the clinical trials until site close out. They will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. They will work collaboratively with the Sponsor Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other Sponsor functional departments (as required) to drive start-up and ongoing oversight of clinical studies. They may have direct reports of Clinical Trial Managers across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality.Responsabilities:Participate in the planning, implementation and management of sponsor clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable sponsor controlled documents.Oversee the site management of CROs and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time.Track site visit and trip report metrics; data quality concerns and site level trending of protocol deviations.Conduct oversight site visits including pharmacy visits, as required, to evaluate site and CRA performance and ensure adherence to study protocols, study operation plans, ICH GCP and regulatory requirementsAttend and assist, as required, at Initiation visits to confirm site training of therapeutic indication(s) and associated study procedures (e.g. Pharmacy training) and help build and foster sponsor-CRO-Investigator - site relationshipsReview a percentage of CRA monitoring trip reports, ensuring oversight of CRO CRA and Site compliance with protocol, study plans, SOPs and ICH and GCPs, escalate identified report issues and ensure CRO study team resolve identified concerns • Collaborate with sponsor CPM and sponsor Medical Monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met.Manage study start up in collaboration with internal and external project teams (e.g. sponsor Project Manager, Regulatory, Clinical Supplies, Third Party Vendors, CRO) to ensure start up timelines are clearly defined and implemented, working to identify any risks and resolving any issues.Act as subject matter expert for assigned protocols for study related issues, protocol and clinical operational queries arising from CRO, IRB/IECs/RAs, Third Party Vendors and sites.Provide routine updates to the internal project team on study status/issuesManages the CRO/clinical trial site during start-up activities including, but not limited to, budget and contract negotiations, IRB/EC submissions and response and facilitation of essential document collectionProvide direction and support to the CPM in ensuring consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate.Manages consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriateWorks cross-functionally with other sponsor departments (Clinical Supplies, Quality Assurance, Regulatory Affairs) to ensure all clinical trial activities performed by sponsor as a Sponsor are performed according to study requirements and timelines.Contribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, protocol, informed consent documents (master and/or site specific), budgets, monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals, case report form development and training materialsExecute and/or deliver trial specific training as requiredReview of open action items and data trends; working with CROs to escalate and resolve identified issues to ensure standards for monitoring and reporting are met as well as to ensure better efficiencies and execution of our studiesContribute to the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from planSupport study team with site selection while optimizing start-up processes to ensure efficient start-up timelines are met. Attend and present at Investigator Meetings on Clinical Operations topics, as requiredMay oversee the accurate, timely, and complete tracking of laboratory samplesMay represent Clinical Operations in cross-functional initiatives (e.g., start-up, continued process improvements with CROs).Contribute to the development and/or participate in the review of sponsor SOPs, Work Instructions and team policiesContribute to preparation of investigator newsletters or email newsflashes.Supports the internal and external project teams with audits/inspection readiness and activities, resolution of audit/inspection findings and contribution to CAPAs as requiredOversight of direct report(s) study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriateAccountable for ensuring all study deliverables and milestones are met with quality and within timelinesProvide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assetsProvides support/escalation point for direct reports as neededProfile:At least 8 years of relevant clinical operational experience in a biotechnology/pharmaceutical company, and/or CROWorking knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plusExperience with start-up and initiation of clinical trial sitesExperience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where requiredAbility to communicate and coordinate activities with the internal team, clinical sites and vendorsProactively identify project challenges/risks and appropriate corrective actions to the internal study teams and work with internal team, clinical sites and vendors on resolutions with minimal supervisionAbility to work independentlyExperience presenting high level presentations, both orally and in writingKnowledge of and experience with immunotherapies and/or OncologyAt least 2 years of on-site monitoring experienceIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
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Global clinical project manager - vendor management expert - novartis dedicated (home-based in eu...

Reading, South East IQVIA

Posted today

Job Viewed

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Job Description

Global Clinical Project Manager - Vendor Management Expert – Single Sponsor (Novartis) Are you an experienced Vendor Management professional looking to make an impact in global clinical trials?We are seeking a Global Clinical Project Manager - Vendor Management Expert to join our Single Sponsor Department, dedicated exclusively to Novartis. In this role, you 'll become an expert in Vendor Management for global clinical trials across all phases (Phase I–IV), ensuring seamless execution from study start-up through close-out.What We’re Looking ForTo excel in this role, you should bring:Global Clinical Project Management experienceStrong Vendor Management expertise: Central lab, e COA, IRT, ECG, Imaging, Ancillaries and/or Patient Recruitment & Retention with experience in global clinical trials. (must have experience managing at least 2 of these vendors)Deep understanding of clinical operations processes and vendor service categories.Excellent project management skills to drive efficiency and collaborationStrong communication and influencing abilities to partner effectively across functions.Proven ability to manage risk and performance issues in a fast-paced environmentWhat You’ll DoAs a Global Clinical Project Manager - Vendor Management Expert, you will be responsible for ensuring vendor deliverables are met with quality and efficiency at the trial level. Your key responsibilities include:Vendor Oversight & Coordination – Manage vendor activities across the study lifecycle, ensuring timely and high-quality deliverables.Study Start-Up Support – Oversee vendor deliverables during study initiation, ensuring smooth onboarding and activation.Risk & Performance Management – Track vendor performance, identify risks, and escalate issues as needed.Site Readiness & Activation – Drive vendor activities to support site activations and ensure study milestones are met.Study Close-Out – Coordinate vendor deliverables that support Database Lock and study closure.What You’ll DeliverVendor service excellence at the study levelVendor onboarding and performance trackingKPI (Key Performance Indicator) and KQI (Key Quality Indicator) dashboards to monitor vendor effectivenessSite readiness monitoring and documentationRisk mapping with contingency planningVendor cost control and oversightPlease note this role is not eligible for the UK visa sponsorship.This is an exciting opportunity to play a critical role in global clinical trials, ensuring vendor excellence and operational success. If you’re ready to take on a high-impact role with a leading sponsor, we’d love to hear from you!IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

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