599 Clinical Data Management jobs in the United Kingdom
Director Clinical Data Management
Posted 6 days ago
Job Viewed
Job Description
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission-to serve patients-has driven our status as one of the world's preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
**DIRECTOR CLINICAL DATA MANAGEMENT**
**Live**
**What You Will Do**
The Amgen Global Clinical Data Management team is looking for an experienced Director to lead our data management team on the aspiration of optimizing and delivering an industry admired clinical evidence platform to deliver innovative medicines to patients with unmet medical needs.
You will lead and manage Data Management (DM) teams within a specific DM operational business unit. The Director will set and drive forward the vision and strategy for DM as a member of the DM and GSO Leadership Team.
You will be accountable for leadership and oversight of the data management organization; ensuring operational excellence and consistency in clinical trial execution. In this role you will be accountable for building and developing a high performing internal data management team, as well as ensuring engagement and alignment of Amgen's strategy and priorities with the Functional Service Provider (FSP).
In this role you will be part of the Global Study Operations (GSO) leadership team, accountable for the delivery of quality clinical trials through industry-leading execution of innovative processes, strong cross-functional partnerships, and best-use of clinical systems and analytics to guide site and study operations. The role will support acceleration of clinical programs and other continuous improvement efforts, applying innovative thinking in shaping future strategy.
Our Global Clinical Data Management Team:
The Global Clinical Data Management Team comprises approximately 50 people. The three Directors, as part of the wider GSO organization and reporting into the Executive Director, Global Study Operations, work together to meet the demands of an industry leading, fast paced, high throughput organization with a commitment to compliance, quality and standards.
**Responsibilities:**
+ Oversight of a distinct DM operational unit (e.g. therapy area, cross-product area)
+ Recruiting, managing and developing staff
+ Global resource planning and assignments
+ Setting of functional goals and objectives
+ Creating and implementing GSO & DM strategies developing, reviewing, implementing and enforcing data standards
+ Ensuring DM processes/systems meet regulatory and business requirements
+ Be an active member of the Leadership Team to provide a foundation for GSO success
**Key activities will include:**
+ Team management including performance, coaching and development
+ Develop, review and implement policies, SOPs and associated documents affecting DM globally
+ Set vision, strategy and direction for DM group; develop annual goals and objectives
+ Accountable for and oversee DM FSP relationships; ensuring goals of product areas and systems groups can be met via the FSP
+ Define and maintain Service Level Agreements and Key Performance Indicators; including oversight of quality and CAPA management
+ Governance oversight -ensure visibility into performance of FSPs to the department
+ Sponsor, Lead and participate in cross functional working groups
+ Resource and budget management for global function Ensure adequate training and capability within area and be accountable for staff compliance with all DM processes
+ Vendor management (development of strategies, contract management, relationship management, etc)
+ Respond to audit/inspection findings
+ Be accountable for and oversee all study deliverables and submission activities for products within group
+ Ensure that status information on DM activities is available and is acted on as needed
**Win**
**What We Expect Of You**
We are all different, yet we all use our unique contributions to serve patients. The data management professional we seek is a collaborator with these qualifications.
+ Degree educated in relevant field or in life science, computer science, business administration or related discipline
+ Extensive experience in data management in the Pharmaceutical or Biotech arena
+ Experience in rare disease therapeutic area in a leadership role
+ Broad experience of working in a global organization
+ Experience at or oversight of outside vendors (CRO's, central labs, imaging vendors, etc)
+ Extensive managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
+ Strategic and innovative thinker with experience of driving operational excellence
+ Excellent relationship building skills with the ability to influence and make business impact
+ Ability to work collaboratively cross functionally with ability to influence and drive decisions
+ Proven experience within oversight of clinical research suppliers
+ Project management
+ Previous experience in a global, matrix organization
+ Excellent organizational and interpersonal skills
+ Ability to anticipate and problem solve challenging issues
**THRIVE**
**What you can expect of us**
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
+ Vast opportunities to learn and move up and across our global organization
+ Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
+ Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
**LOCATION:** Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
**APPLY NOW**
**for a career that defies imagination**
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
**careers.amgen.com**
**Equal Opportunity Statement**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Clinical Data Management Lead
Posted 6 days ago
Job Viewed
Job Description
+ Serve as primary point of contact for customer on data management deliverables
+ Manage multiple large studies or program of studies (possibly global)
+ Provide leadership and senior support to DTLs on multiple large global programs of global studies
+ Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
+ Lead direct negotiations with customer, e.g., timelines, financial, process, resources
+ Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
+ Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
+ Serve as the escalation point for unresolved data issues
+ Ensure appropriate resources are assigned to meet project deliverables
+ Create and/or review and sign-off on all data management plan (DMP) documents
+ Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
+ Serve as Subject Matter Expert (SME)
+ Provide leadership and expertise in a specific CDM task or technology
+ Independently manage SOW/budget
+ Independently bring process improvements and solutions to the CDM team/CDM department
+ Lead a focus team or global or local best practice team
+ Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions
**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**
+ Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients)
+ Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation)
+ Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently
+ Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
+ Knowledge of operating procedures and work instructions and the ability to apply them in practice
+ Knowledge of Good Clinical Practices and relevant regulatory guidelines
+ Excellent communication, interpersonal, customer service, and teamwork skills
+ Excellent organizational and problem-solving skills
+ Excellent project management skills
+ Ability to work independently
+ Comprehensive understanding of clinical drug development process
+ Ability to establish and maintain effective working relationships with co-workers, managers and customers
**MINIMUM REQUIRED EDUCATION AND EXPERIENCE**
+ Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
+ Around 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and 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
Clinical Trials Prosthetist
Posted 8 days ago
Job Viewed
Job Description
Do you want to put your clinical expertise to work in a whole new way?
Help shape the future of Blatchford products by using your clinical insight to help bring amazing ideas to reality that truly make a difference.
Blatchford is a multi-award winning, global manufacturer of some of the world’s most advanced prosthetic technology, bespoke seating solutions and orthotic devices. Our evidence-based approach and commitment to continuously challenge possibilities ensures our mobility solutions prioritise the wellbeing and long-term health of our users.
Through science, technology, and maintaining a clear focus on people, we make mobility possible.
We are driven by a clear purpose: to deliver superior clinical outcomes. We have a brand new, exciting opportunity for a Clinical Trials Prosthetist to strengthen our global clinical research team and ensure our pioneering technologies are validated with the highest standards of safety, ethics, and scientific rigor.
The role
As Clinical Trials Prosthetist , you will focus on prosthetic products, along with supporting other product/clinical areas. This is a flexible opportunity to share your expertise, influence product development, and help bring innovative mobility solutions to life.
Key duties:
- Providing clinical oversight for all participants in Blatchford-sponsored clinical trials across our varied products.
- Providing direct clinical input to our prosthetic R&D and Marketing advocates to maintain your clinical registration.
- Ensuring compliance with clinical trial protocols, Good Clinical Practice and regulatory requirements.
- Supporting trial design by contributing clinical expertise to protocol development, feasibility assessments, and outcome measures.
- Liaising with our clinical teams based in the UK and Norway and our global educators to ensure their ‘on the ground’ feedback is heard and incorporated when appropriate.
- Presenting our clinical findings at national and international conferences
- Serving as the clinical point of contact for investigators, study coordinators, regulatory authorities, and internal teams.
- Overseeing accurate clinical documentation and supporting the interpretation of trial data.
- Contributing to Blatchford’s mission of advancing mobility by ensuring our innovations are validated with robust clinical evidence.
What can we offer you?
As Clinical Trials Prosthetist, you will receive the following:
Benefits
- Highly competitive salary
- Flexible, hybrid working.
- 25 days holiday (rising with service)
- Option to purchase additional annual leave.
- Pension
- Death in service
- Discounted shopping and leisure activities
- Health cash plan
- Cycle to work scheme.
- A meaningful role where your work directly improves patients’ mobility and independence.
- A collaborative, international research environment at the forefront of medical technology.
- Opportunities for professional growth and development within a global innovation leader.
What are we looking for?
Key skills
- Qualified Prosthetist experience.
- Good level of clinical experience.
- Strong product knowledge in lower-limb prosthetics, including familiarity with microprocessor and mechanical prosthetic systems.
- Have experience of clinical trials or research.
- Good knowledge of ethics, and regulatory standards.
- Excellent communication and collaboration skills, with the ability to work across multidisciplinary and international teams.
- Passionate about advancing patient outcomes and bringing life-changing technologies to market.
If you feel like you meet the above criteria for this exciting Clinical Trials Prosthetist opportunity, then please apply now!
Clinical Trials Pharmacist
Posted today
Job Viewed
Job Description
The trials team is expanding, and we have a fantastic opportunity for a passionate, motivated, and dynamic pharmacist to join the Pharmacy Clinical Trials team at The Royal Marsden (RMH) NHS Foundation Trust.
An exciting time to join our service, focussing on delivering high-quality care to patients and staff. The RMH is a world-leading cancer centre with sites in Chelsea and Sutton, plus a Medical Day Care Unit at Kingston Hospital.
Prior clinical trials experience; oncology or haemato-oncology knowledge is an advantage. Working alongside pharmacists, technicians, and assistants as part of a Multi-Disciplinary Team committed to delivering outstanding patient care.
Our team supports the research strategy of "taking personalized cancer treatment to the next level," with approximately 380 active IMP studies and increasingly complex new clinical trials across all specialties, including gene therapies and cellular therapies studies.
The RMH, in association with its partner, The ICR, has an unparalleled global reputation for patient care, research, and education. Through our partnership, we pioneer new cancer therapies through complex transitional studies and Phase I-III clinical trials, making us one of
Europe's largest comprehensive cancer centres.
The hospital has recently introduced the EPIC digital health record system, and we are looking to use the full capabilities of this system to support the pharmacy teams and become a more efficient and truly paperless.
- To contribute to the provision of the pharmacy clinical trials service to the Dispensaries (Chelsea & Sutton), Medical day Unit, West Wing Clinical Research Centre (WWCRC), Oak ward and day case areas of the Drug Development Unit and the Clinical Trial Dispensary across both sites.
- To assist the Clinical Trials Team with any day-to day clinical, dispensing, ward and research day units' queries.
- To provide clinical trials advice while covering the research clinics and attending MDT.
- To support research clinic prescribing
- Provide clinical trial support and advice to other areas within pharmacy e.g. aseptic service, clinical services and to the research teams.
- To support the clinical trial team with clinical trial set-up of new studies, revision of amendments for ongoing studies already open at the trust, to provide continued support for the running and maintenance of current trial activity.
- To contribute to the provision of the pharmacy clinical trials service to the individual clinical units, R&D and the Trust.
The RMH NHS Foundation Trust is a world-leading cancer centre, offering patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We have two hospitals – one in Chelsea, London, and one in Sutton, Surrey – as well as a Medical Day-care Unit in Kingston Hospital
At RMH, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.
At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits and learning and development opportunities.
We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements. A variety of other staff benefits including employee assistance programme, discounted gym membership, onsite fitness classes, car schemes.
For further information on this role, please see the attached detailed Job Description and Person Specification:
Ensure that clinical trial services policies and procedures are adhered to and accreditation records and training documents are completed appropriately.
Promote optimal and appropriate drug use and high quality prescribing practice within the Trust.
To respond appropriately to requests from medical and nursing staff for information and advice about selection and use of drug therapy.
Support the Lead Pharmacist, Clinical R&D and the Chief Technician, Clinical Trials in work towards maintaining quality standards required by Medicines and Health products Regulatory Agency and ensuring principles of Good Clinical Practice are applied at all times.
To support the Lead Pharmacist, Clinical R&D with the Clinical Governance and Risk Management Strategy within the department and throughout the Trust.
Take part in clinical trials audit or any other project work relevant to this post.
Participate in any pharmacy initiatives or working groups as appropriate.
To support the Trial Team in maintaining up to date of Key Performance Indicators for all trail activities.
Clinical Trials Manager
Posted 9 days ago
Job Viewed
Job Description
- Developing comprehensive clinical trial protocols and study plans.
- Identifying, selecting, and managing investigative sites and study personnel.
- Overseeing the day-to-day operations of clinical trials, including patient recruitment, data collection, and monitoring.
- Ensuring compliance with all applicable regulatory requirements (e.g., FDA, EMA, MHRA) and Good Clinical Practice (GCP).
- Managing clinical trial budgets and timelines effectively.
- Developing and maintaining strong relationships with investigators, study coordinators, and other stakeholders.
- Preparing and submitting study-related documents, including Investigator Brochures and Essential Documents.
- Risk assessment and mitigation planning for clinical trials.
- Managing vendors and external service providers involved in clinical trials.
- Contributing to the development and implementation of Standard Operating Procedures (SOPs) related to clinical trial management.
- Ensuring accurate and timely data management and reporting.
- Leading and motivating clinical research associates (CRAs) and other study team members.
- Bachelor's or Master's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 5 years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
- In-depth knowledge of GCP, ICH guidelines, and regulatory submission processes.
- Proven experience in managing multiple clinical trials simultaneously.
- Strong project management skills with a demonstrated ability to manage complex projects.
- Excellent leadership, communication, and interpersonal skills.
- Proficiency in clinical trial management software and electronic data capture (EDC) systems.
- Ability to travel as required to investigative sites and meetings.
- Strong problem-solving abilities and attention to detail.
- Experience in (specific therapeutic area, e.g., oncology, cardiology) is a significant advantage.
Clinical Trials Prosthetist
Posted today
Job Viewed
Job Description
Do you want to put your clinical expertise to work in a whole new way?
Help shape the future of Blatchford products by using your clinical insight to help bring amazing ideas to reality that truly make a difference.
Blatchford is a multi-award winning, global manufacturer of some of the world’s most advanced prosthetic technology, bespoke seating solutions and orthotic devices. Our evidence-based approach and commitment to continuously challenge possibilities ensures our mobility solutions prioritise the wellbeing and long-term health of our users.
Through science, technology, and maintaining a clear focus on people, we make mobility possible.
We are driven by a clear purpose: to deliver superior clinical outcomes. We have a brand new, exciting opportunity for a Clinical Trials Prosthetist to strengthen our global clinical research team and ensure our pioneering technologies are validated with the highest standards of safety, ethics, and scientific rigor.
The role
As Clinical Trials Prosthetist , you will focus on prosthetic products, along with supporting other product/clinical areas. This is a flexible opportunity to share your expertise, influence product development, and help bring innovative mobility solutions to life.
Key duties:
- Providing clinical oversight for all participants in Blatchford-sponsored clinical trials across our varied products.
- Providing direct clinical input to our prosthetic R&D and Marketing advocates to maintain your clinical registration.
- Ensuring compliance with clinical trial protocols, Good Clinical Practice and regulatory requirements.
- Supporting trial design by contributing clinical expertise to protocol development, feasibility assessments, and outcome measures.
- Liaising with our clinical teams based in the UK and Norway and our global educators to ensure their ‘on the ground’ feedback is heard and incorporated when appropriate.
- Presenting our clinical findings at national and international conferences
- Serving as the clinical point of contact for investigators, study coordinators, regulatory authorities, and internal teams.
- Overseeing accurate clinical documentation and supporting the interpretation of trial data.
- Contributing to Blatchford’s mission of advancing mobility by ensuring our innovations are validated with robust clinical evidence.
What can we offer you?
As Clinical Trials Prosthetist, you will receive the following:
Benefits
- Highly competitive salary
- Flexible, hybrid working.
- 25 days holiday (rising with service)
- Option to purchase additional annual leave.
- Pension
- Death in service
- Discounted shopping and leisure activities
- Health cash plan
- Cycle to work scheme.
- A meaningful role where your work directly improves patients’ mobility and independence.
- A collaborative, international research environment at the forefront of medical technology.
- Opportunities for professional growth and development within a global innovation leader.
What are we looking for?
Key skills
- Qualified Prosthetist experience.
- Good level of clinical experience.
- Strong product knowledge in lower-limb prosthetics, including familiarity with microprocessor and mechanical prosthetic systems.
- Have experience of clinical trials or research.
- Good knowledge of ethics, and regulatory standards.
- Excellent communication and collaboration skills, with the ability to work across multidisciplinary and international teams.
- Passionate about advancing patient outcomes and bringing life-changing technologies to market.
If you feel like you meet the above criteria for this exciting Clinical Trials Prosthetist opportunity, then please apply now!
Clinical Trials - Sales Lead
Posted today
Job Viewed
Job Description
Who we are:
We are Vet-AI, and we are delivering the future of pet care and clinical research. While our flagship app, Joii Pet Care, makes pet care affordable and accessible for all pet owners, we are also at the forefront of digital veterinary trials. Our platform enables efficient and effective clinical research for veterinary medicine, leveraging the insights gained from Joii's extensive user base.
Our mission:
- To make pet care affordable and accessible for everyone.
- To improve the lives and wellbeing of everyone working within the veterinary industry.
- To advance veterinary medicine through digitally led trials, using Joii Pet Care to connect research sponsors with pet owner databases
Quite simply, we want vet care to be available to everyone, to ensure the people who are delivering it with us are as happy as they can be, and to drive innovation in animal health through our trials platform, all while keeping the spirit of Joii alive.
Role Summary:
As Clinical Trials - Sales Lead, you will take full ownership of the sales function for our Clinical Trials business line. You’ll be responsible for developing strategy, building a high-quality pipeline, and converting opportunities into long-term partnerships with pet food companies and other pet care businesses.
Working closely with leadership, you will design client solutions and ensure a seamless journey from first contact through to proposal and closure. This is a unique opportunity to shape and grow a key revenue stream in a scaling business.
Job Responsibilities:
- Define and implement a sales strategy for the Clinical Trials division.
- Own the end-to-end sales cycle: prospecting, lead generation, consultative solution design, proposal development, negotiation, and closing.
- Build strong relationships with decision-makers in the pet food and pet care industries.
- Maintain a healthy, well-documented sales pipeline with accurate forecasting and reporting.
- Collaborate with internal teams to design solutions that deliver real value for clients.
- Represent the company at industry events, conferences, and networking forums.
Essential:
- We are looking for someone ambitious, commercially minded, and excited about scaling a business in a dynamic sector.
- Proven track record in clinical trials sales, pet care, healthcare, or life sciences.
- Experience selling into pet food companies and the wider pet care sector.
- Demonstrated success in building and managing a sales pipeline.
- Strong consultative sales skills, with the ability to design and present compelling solutions.
- Experience working in a startup or scale-up environment, comfortable building processes and taking ownership.
- Excellent communication, influencing, and relationship management skills.
Desirable:
- Established a network within the pet food or pet care industries.
- Knowledge of clinical trial operations, regulatory frameworks, or R&D partnerships in pet health.
Our brand values:
Brave;
- We are not afraid to disrupt the status quo. Championing what’s right for pets and standing confidently behind our purpose. Even when it’s challenged.
- We have the courage and confidence to tackle things that nobody has done before.
- We may face hurdles, adversity, and the fear of failure but we have the conviction to keep going.
Boundless;
- We do not constrain ourselves to the expectations of traditional pet care; we’re young, bright and full of fresh ideas.
- We bring energy and pro-activity to everything we do. We’re problem solvers, with a ‘can do’ outlook.
- Our boundless attitude brings the joy.
Togetherness;
- We share an ‘in-it-together’ mindset. We’re one team; we don’t leave anyone to face problems alone when we can help.
- We champion empathy and compassion; caring about what our customers and our colleagues are going through. Going above and beyond when they need us.
- We strive for constant collaboration, no matter where we are in the world
What you’ll get:
We are a startup transitioning to a scale-up, so if you like a slow pace, we’re not the company for you. However, if you do like a supportive team, a fun culture, and the feeling of creating incredible work - you’ll fit right in! Some of the perks you’ll get with us are:
Fully remote (UK
Access to a co-working space budget
Private Medical Insurance & Group Life Assurance
Be The First To Know
About the latest Clinical data management Jobs in United Kingdom !
Remote Clinical Trials Coordinator
Posted 10 days ago
Job Viewed
Job Description
Key Responsibilities:
- Coordinate all aspects of assigned clinical trials remotely, adhering to study protocols and Good Clinical Practice (GCP) guidelines.
- Assist in the preparation and submission of study-related documents, including Investigational New Drug (IND) applications and Institutional Review Board (IRB) submissions.
- Recruit, screen, and enroll eligible participants for clinical trials, conducting initial remote assessments and consultations.
- Schedule and manage participant appointments, ensuring adherence to the trial schedule and protocol requirements.
- Collect, manage, and maintain accurate study data in electronic data capture (EDC) systems.
- Monitor study progress, identify potential issues or deviations, and implement corrective actions as needed.
- Communicate effectively with investigators, study coordinators, and other site personnel to ensure smooth trial operations.
- Prepare and submit regulatory and progress reports as required.
- Ensure the proper storage and handling of investigational products and biological samples.
- Maintain all study-related documentation and files in a compliant and organized manner.
- Conduct remote monitoring visits to ensure protocol adherence and data integrity.
- Provide support and education to study participants regarding trial procedures and requirements.
- Bachelor's degree in a life science, nursing, or a related field; Master's degree preferred.
- Minimum of 3-5 years of experience in clinical research coordination or a similar role.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Proficiency with electronic data capture (EDC) systems and other clinical trial management software.
- Excellent organizational, time management, and multitasking abilities.
- Strong written and verbal communication skills, with the ability to communicate effectively with diverse stakeholders.
- Demonstrated ability to work independently and proactively in a remote setting.
- Detail-oriented with a commitment to data accuracy and integrity.
- Experience in specific therapeutic areas (e.g., oncology, cardiology) is a plus.
- Certification as a Clinical Research Professional (e.g., ACRP, SoCRA) is highly desirable.
Pharmaceutical Clinical Trials Project Manager
Posted 4 days ago
Job Viewed
Job Description
Senior Project Manager - Clinical Trials
Posted 20 days ago
Job Viewed
Job Description
Key Responsibilities:
- Lead and manage all phases of clinical trials, from study start-up to database lock and close-out.
- Develop comprehensive clinical trial project plans, including timelines, budgets, and resource allocation.
- Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and other relevant regulatory requirements.
- Oversee the selection and management of clinical trial sites and vendors (e.g., CROs, central labs).
- Develop and manage study budgets, tracking expenditures and ensuring financial accountability.
- Lead and motivate cross-functional clinical trial teams, fostering a collaborative and high-performing environment.
- Monitor trial progress, identify risks and issues, and implement mitigation strategies.
- Prepare and present project status reports to senior management and key stakeholders.
- Liaise with regulatory authorities, ethics committees, and investigators.
- Ensure the quality and integrity of clinical trial data.
- Contribute to the continuous improvement of clinical trial processes and best practices.
- Bachelor's or Master's degree in a life science, healthcare, or related field.
- Minimum of 7 years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
- Proven track record of successfully managing multiple complex clinical trials simultaneously.
- In-depth knowledge of clinical trial operations, regulatory requirements (e.g., FDA, EMA), and GCP.
- Strong project management skills, with experience using project management software.
- Excellent leadership, communication, and interpersonal skills.
- Ability to manage budgets and resources effectively.
- Proficiency in data management and analysis related to clinical trials.
- Experience working effectively in a fully remote, international team environment.
Explore opportunities in clinical data management, a field vital to pharmaceutical research and healthcare innovation. Clinical