671 Clinical Data Specialists jobs in the United Kingdom

Clinical Data Management Lead

Reading, South East IQVIA

Posted 7 days ago

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Job Description

**RESPONSIBILITIES**
+ 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
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Senior Clinical Data Manager - Oncology Trials

CV1 1AA Coventry, West Midlands £65000 Annually WhatJobs

Posted 17 days ago

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full-time
Our client, a prominent contract research organisation (CRO) in the pharmaceutical sector, is seeking an experienced Senior Clinical Data Manager to oversee critical oncology clinical trials. This is a fully remote, permanent position, offering the flexibility to work from anywhere within the UK. You will be responsible for the end-to-end management of clinical trial data, ensuring its accuracy, integrity, and compliance with regulatory standards (e.g., FDA, EMA, ICH GCP). Your duties will include designing clinical databases, developing data management plans, leading data validation activities, and managing data entry and query resolution processes. You will collaborate closely with clinical operations, biostatistics, and regulatory affairs teams to ensure seamless data flow and timely database lock. The ideal candidate will possess a Bachelor's degree in a life science, health-related field, or computer science, along with at least 5-7 years of progressive experience in clinical data management, with a significant focus on oncology trials. Proficiency in EDC systems (e.g., Medidata Rave, Oracle Clinical) and strong knowledge of CDISC standards (SDTM, ADaM) are essential. Excellent analytical, problem-solving, and communication skills are required, along with meticulous attention to detail. You will mentor junior data managers, contribute to process improvements, and ensure adherence to standard operating procedures. This role requires a deep understanding of the drug development lifecycle and the critical role of high-quality data in supporting regulatory submissions and therapeutic advancements. If you are a dedicated data professional seeking a challenging and rewarding remote opportunity within a leading CRO, this role offers the chance to make a substantial impact on cancer research. This position is based in Coventry, West Midlands, UK , but operates entirely remotely.
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Clinical Trials Prosthetist

Basingstoke, South East Blatchford

Posted 8 days ago

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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!

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Clinical Trials Pharmacist

Chelsea, London NHS

Posted today

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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.

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Clinical Trials Manager

SO15 0AA Southampton, South East £50000 Annually WhatJobs

Posted 10 days ago

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Job Description

full-time
Our client is seeking an experienced and diligent Clinical Trials Manager to oversee the planning, execution, and monitoring of clinical studies within their pharmaceutical division. This critical role, based in our Southampton, Hampshire, UK facility, requires a strong understanding of clinical trial processes, regulatory requirements, and project management principles. You will be responsible for ensuring that all trials are conducted in accordance with protocol, GCP guidelines, and ethical standards, while maintaining the highest quality and integrity of data. Responsibilities will include:
  • 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.
Qualifications:
  • 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.
This is an exceptional opportunity for a dedicated professional to play a pivotal role in bringing life-changing medicines to patients by ensuring the successful execution of clinical trials.
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Clinical Trials Prosthetist

New
Basingstoke, South East Blatchford

Posted today

Job Viewed

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Job Description

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!

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

Principal Clinical Data Manager

S1 1DA Sheffield, Yorkshire and the Humber £85000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
A leading pharmaceutical research organization is seeking a highly skilled Principal Clinical Data Manager for their operations in Sheffield, South Yorkshire, UK . This role is pivotal in ensuring the integrity, accuracy, and quality of clinical trial data. You will be responsible for overseeing all aspects of clinical data management, from database design and setup to data validation, cleaning, and database lock. Your expertise will ensure compliance with regulatory requirements and company standards.

Key responsibilities include developing clinical data management plans, creating data validation specifications, and managing external vendors involved in data management activities. You will lead and mentor a team of data managers, providing guidance and support to ensure efficient and effective data collection and processing. The ideal candidate will possess a Bachelor's or Master's degree in a scientific or healthcare-related field, with a minimum of 8 years of experience in clinical data management, including significant experience in a leadership or principal role. A strong understanding of clinical trial processes, CDISC standards (SDTM, ADaM), and various EDC systems (e.g., Medidata Rave, Oracle Clinical) is essential. Excellent analytical, problem-solving, and communication skills are required, along with meticulous attention to detail. Experience with database programming and query writing is highly desirable. This is an excellent opportunity to contribute to critical drug development programs and advance your career in a highly respected pharmaceutical organization.
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Senior Clinical Data Manager

L3 9DT Liverpool, North West £55000 Annually WhatJobs

Posted 11 days ago

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Job Description

full-time
Our client is seeking a highly experienced and meticulous Senior Clinical Data Manager to join their dynamic pharmaceutical research team. This role plays a critical part in ensuring the integrity, accuracy, and reliability of clinical trial data, which is essential for regulatory submissions and drug development. You will be responsible for overseeing the design, development, and execution of clinical databases, managing data entry processes, and ensuring compliance with all relevant data management standards and regulatory guidelines (e.g., ICH GCP). The Senior Clinical Data Manager will lead data management activities across multiple clinical trials, collaborating closely with clinical operations, biostatistics, and medical coding teams. Key responsibilities include developing data management plans (DMPs), creating case report forms (CRFs), establishing data validation checks, and performing data cleaning activities. You will also manage user acceptance testing (UAT) for clinical databases and work with external vendors as needed. This position requires a strong understanding of clinical trial processes, database technologies (e.g., EDC systems like Medidata Rave, Oracle Clinical), and data quality principles. The ideal candidate will possess excellent analytical and problem-solving skills, with a keen eye for detail and a commitment to data accuracy. Leadership potential and the ability to mentor junior data managers are highly valued. While this role offers a hybrid work arrangement, flexibility to attend key meetings on-site in Liverpool will be expected. You will contribute significantly to the successful execution of clinical studies, ensuring that high-quality data supports critical research outcomes.

Responsibilities:
  • Develop and implement comprehensive Data Management Plans (DMPs) for clinical trials.
  • Design, build, and maintain clinical databases using Electronic Data Capture (EDC) systems.
  • Oversee the creation and validation of Case Report Forms (CRFs) and data entry guidelines.
  • Establish and execute data validation procedures, including query generation and resolution.
  • Ensure data accuracy, completeness, and consistency throughout the clinical trial lifecycle.
  • Perform data review and cleaning activities in accordance with protocols and DMPs.
  • Manage User Acceptance Testing (UAT) for clinical databases and related systems.
  • Collaborate with cross-functional teams, including biostatistics, clinical operations, and regulatory affairs.
  • Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and other relevant regulations.
  • Contribute to the development and maintenance of standard operating procedures (SOPs) for data management.
  • Act as a subject matter expert for clinical data management within the organisation.
  • Mentor and provide guidance to junior clinical data management personnel.
Qualifications:
  • Bachelor's degree in a life science, computer science, or related field.
  • Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotech industry.
  • Proven experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva).
  • Strong understanding of ICH-GCP guidelines and regulatory requirements for clinical data.
  • Excellent knowledge of database design, data validation, and data cleaning processes.
  • Proficiency in clinical trial methodologies and terminology.
  • Strong analytical and problem-solving abilities with meticulous attention to detail.
  • Effective communication and interpersonal skills, with the ability to work collaboratively in a hybrid team environment.
  • Experience in leading data management activities for multiple studies is advantageous.
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Principal Clinical Data Manager

L1 8JQ Liverpool, North West £75000 Annually WhatJobs

Posted 19 days ago

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Job Description

full-time
Our client, a leading pharmaceutical research organization, is seeking a Principal Clinical Data Manager to join their globally distributed team. This is a fully remote position, offering the flexibility to work from anywhere while contributing to critical pharmaceutical development projects. You will be responsible for overseeing the design, development, and implementation of clinical databases, ensuring data integrity, accuracy, and compliance with regulatory standards. This senior role requires extensive experience in clinical data management, a deep understanding of CDISC standards, and strong leadership capabilities. You will play a crucial role in the success of clinical trials, ensuring that data is managed efficiently and effectively to support regulatory submissions and therapeutic advancements.

Key Responsibilities:
  • Lead the design, setup, and maintenance of clinical databases according to study protocols and therapeutic area requirements.
  • Develop and implement data management plans (DMPs), edit check specifications, and data validation procedures.
  • Oversee data cleaning activities, issue resolution, and database lock processes for clinical trials.
  • Ensure compliance with Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other relevant regulatory requirements.
  • Develop and maintain standard operating procedures (SOPs) and work instructions for clinical data management.
  • Provide technical expertise and guidance on clinical data management best practices.
  • Mentor and train junior data managers and data management staff.
  • Act as a key point of contact for data management activities, collaborating with clinical operations, biostatistics, programming, and medical teams.
  • Participate in the selection and implementation of data management technologies and tools.
  • Conduct quality control checks and audits to ensure data accuracy and consistency.
  • Contribute to the development of integrated data management strategies across multiple projects and therapeutic areas.
  • Review and approve data management-related documents, including CRFs, database specifications, and validation reports.
  • Proactively identify risks and issues related to data management and implement mitigation strategies.
  • Stay current with industry trends, regulatory changes, and advancements in clinical data management.

Required Qualifications:
  • Bachelor's degree in a scientific, technical, or health-related field. Master's degree preferred.
  • Minimum of 10 years of progressive experience in clinical data management within the pharmaceutical or biotechnology industry.
  • Extensive knowledge of clinical trial processes and regulatory requirements (GCP, ICH, FDA).
  • Proficiency in CDISC standards (SDTM, ADaM) and experience with data warehousing solutions.
  • Strong experience with clinical data management systems (e.g., Medidata Rave, Oracle Clinical, SAS).
  • Proven ability to lead data management activities for complex, global clinical trials.
  • Excellent understanding of database design, data validation techniques, and data cleaning processes.
  • Strong leadership, project management, and problem-solving skills.
  • Exceptional communication, presentation, and interpersonal skills.
  • Ability to work independently and collaboratively in a remote team environment.
  • Experience in mentoring and developing data management professionals.

This fully remote role offers a significant opportunity to influence drug development and advance your career at the forefront of pharmaceutical innovation.
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Remote Clinical Data Manager

M1 1AA Manchester, North West £65000 Annually WhatJobs

Posted 21 days ago

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full-time
This is a fully remote opportunity for a skilled Clinical Data Manager to join a leading global pharmaceutical research organization. Our client is at the forefront of developing life-changing therapies and seeks a dedicated professional to manage and oversee clinical trial data from study start-up through database lock. You will be responsible for developing Data Management Plans (DMPs), designing Case Report Forms (CRFs), and establishing data validation checks and edit specifications in accordance with protocol requirements and regulatory guidelines (e.g., ICH GCP). This role involves leading data cleaning activities, ensuring the accuracy, completeness, and integrity of clinical trial data. You will collaborate closely with biostatisticians, clinical research associates (CRAs), study managers, and external vendors to resolve data discrepancies and queries in a timely manner. Database validation and User Acceptance Testing (UAT) will be key responsibilities, ensuring the clinical database meets all functional and data integrity requirements. You will also contribute to the development and maintenance of data management SOPs and work instructions. A strong understanding of CDISC standards (SDTM and ADaM) and EDC systems (e.g., Medidata Rave, Oracle InForm) is essential. Experience in managing data for Phase I-IV clinical trials across various therapeutic areas is highly desirable. The ideal candidate will possess a Bachelor's degree in a scientific discipline, computer science, or a related field, with a minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry. Exceptional attention to detail, strong organizational skills, and the ability to manage multiple projects simultaneously are crucial. Excellent communication and interpersonal skills are necessary for effective remote collaboration. This is a remote-first position, offering the flexibility to work from anywhere within the UK, with regular virtual team meetings and collaboration. If you are a proactive and experienced Clinical Data Manager looking for a challenging and rewarding remote role, we encourage you to apply.
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