211 Clinical Monitoring jobs in the United Kingdom

Clinical Trainer - Haemodynamic monitoring

Leeds, Yorkshire and the Humber BMS Performance

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Clinical Trainer – Haemodynamic monitoring

North

Medical

Salary £45,000 to £0,000 basic, Bonus k+ uncapped


  • Exciting field-based clinical training and support role
  • North
  • Superb company culture!
  • Work with life-saving equipment in critical care
  • Well respected manufacturer established for 60 years
  • Great opportunity for an ICU Nurse seeking a new challenge


THE ROLE: As the Clinical Trainer, you will be responsible for training clinical end users, such as anaesthetists, on the company’s flagship piece of haemondynamic monitoring equipment and critical care consumables. Working alongside your colleagues in sales, you will play a key role in solidifying relationships with customers as you support their own professional development through ongoing training and assisting with clinical evaluations.


YOUR CAREER : This organisation has a number of different business units and encourage successful employees to move within the company. This business really believes in developing the skills of their employees, making this a fantastic opportunity for somebody looking to learn and get outside of their comfort zone.


THE PERSON: To be considered for this Clinical Trainer role we are looking for:


· A clinician with good understanding of haemodynamic monitoring.

· ICU nurse or theatre nurse with experience of haemodynamic monitoring

· Ideally previous experience of training others

· Bags of passion and energy!

· Able to travel throughout the North of the UK as needed


THE COMPANY : Originally founded in the 1960’s, this European Med-tech manufacturer has gone on to become one of the best know players in their field. As well as offering fantastic development opportunities and the stability that comes with working for a well-run business, you will enjoy a fantastic company culture. This is an organization that truly values its employees and celebrates and rewards everybody’s success and hard work. With a policy of transparent equality, there are no hidden agenda or politics at play that often come with a company of this size.


THE PACKAGE FOR THE CLINICAL TRAINER:

  • Basic salary: £45,000 - £ ,000
  • Bonus: ,000
  • Hybrid car or car allowance of 50 per month
  • Benefits: Pension, healthcare, laptop, mobile, 25 days’ holiday + stats + Full Benefits


Location : Field based job covering the North of the UK including Birmingham, Leicester, Manchester, Leeds, Liverpool, Newcastle, Edinburgh, Glasgow

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Clinical Data Manager

Carrot Recruitment

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Carrot Recruitment are acting as a recruitment agency on the sourcing of a Clinical Data Manager for a clinical-stage biotechnology company at the forefront of cancer drug development. Our client combines cutting-edge science with a patient-centric approach, offering a dynamic and mission-driven work environment. With recent strategic investments from major pharmaceutical partners, the company is well-funded and poised for significant growth.


This is a unique opportunity to contribute to the development of transformational therapies that aim to improve the lives of people with difficult-to-treat cancers who are classified as a top biotech to watch in this space



Everything you need to know about the role

As the Clinical Data Manager, you’ll have significant recent experience of managing all activities related to clinical data, and at all stages of process. You will be the responsible for all elements of the clinical data management and be able to showcase your ability to work in an agile and fast paced environment, with integrity and accuracy


  • Serve as the lead Data Manager on a study level and contribute to the design of the eCRF, collection of data and review of data for accuracy and completeness
  • Interact with members of the multidisciplinary project teams to provide ongoing data management support for clinical trials
  • Familiarity with risk-based data management process
  • Oversee database builds, including UAT, ensuring data integrity and security
  • Participate in the development and implementation of the standard processes and guidelines for the DM function
  • Management of data management tasks, on a study level performed by the vendor, in adherence with established standards including third party vendor data reconciliation, protocol deviation collection, SAE reconciliation and data issue resolution
  • Coordinate internal cross functional review of data management documents, as required
  • Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development



Experience and qualities that make you a strong fit


  • Bachelor’s degree in computer science, life sciences or equivalent
  • Recent relevant experience in a Clinical Data role
  • Current and up-to-date GCP training
  • Experience in setting up EDC systems is essential, and vendor management experience preferred
  • Experience in oncology essential, multiple myeloma preferred.
  • In-depth understanding of clinical trial processes and involved functional stakeholders
  • Knowledge of FDA, EMA and ICH regulations/guidelines and the drug development process is preferred but not essential
  • Proficient in Excel



What’s on offer?


  • A competitive salary
  • Comprehensive benefits package, including medical insurance, pension, bonus and share scheme.
  • Hybrid working model - 2 days per week on site (Manchester location preferred, although commuting distant Cambridge would also be possible)
  • Opportunities to be part of a fast-growing biotech at a significant part of their development.



Could this be the role for you?


If you’re ready to take on this exciting opportunity and bring your expertise to a company that’s listed as one to watch, we’d love to hear from you. Please apply with your most recent CV, to be considered.

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Clinical Data Manager

Northreach

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Overview

We are seeking an experienced Clinical Data Manager to join our Clinical Operations team. In this pivotal role, you will oversee and manage fully outsourced data management activities to ensure high-quality, timely, and compliant clinical data to support regulatory submissions and clinical development goals. This is a new role where you will take ownership of data oversight across all clinical studies. You will collaborate closely with CROs, vendors, internal cross-functional teams, and external stakeholders to ensure data integrity and operational excellence.


Key Responsibilities

  • Serve as the primary data management contact for assigned clinical studies.
  • Oversee CROs and vendors to ensure timely, high-quality delivery of all data management activities in compliance with GCP, ICH, and regulatory requirements.
  • Review and approve essential data management documentation, including Data Management Plans (DMPs) and validation specifications.
  • Ensure efficient execution of database go-live, interim reviews, and database lock processes.
  • Monitor data quality and resolve issues proactively to maintain data integrity.
  • Support regulatory submissions by ensuring availability of clean, compliant datasets.
  • Stay current with industry standards and regulatory trends to drive continuous improvement in data management practices.


Must Haves

  • Significant clinical data management experience, preferably in a biotech or pharmaceutical environment.
  • Experience overseeing fully outsourced data management with CRO oversight.
  • Strong understanding of GCP, ICH guidelines, and regulatory requirements for clinical data.
  • Proficiency in EDC systems (e.g., Medidata Rave, Veeva EDC, Oracle Inform) and data review tools.


Why Join Us?

  • Make a significant impact in an innovative and growing biotech company .
  • Collaborative and innovative work environment.
  • Competitive salary and benefits package.
  • Remote working with regular team meetings.
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Associate Clinical Data Manager

Greater London, London IXICO

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Advanced analytics. Intelligent insights.

IXICO plc (AIM: IXI), is a leading neuroimaging Contract Research Organization (CRO), delivering advanced Ai analytical insights in neuroscience to the global clinical trials market. Established in 2004, listed as a public company in 2013, IXICO has firmly established itself as a trusted partner to the global life sciences industry, supporting the development of new therapies for neurological conditions such as Alzheimer’s, Parkinson’s, Huntington’s Disease and Multiple Sclerosis.


With our focus on neuroscience, our purpose is to advance human health by turning data into clinically valuable insights; helping our clients reduce clinical development risk and improve return on investment from their clinical development programmes. We achieve this by combining Ai machine learning imaging biomarker analysis, together with centralised neuroimaging CRO services to provide an integrated service covering every stage of clinical development through to post-marketing surveillance. We are committed to invest in continuously enhancing our validated and peer reviewed disease optimised machine learning Ai analytics services and our infrastructure and technology to support our ambitious growth strategy. Our people are empowered to enable us to achieve our company goals and their own personal development through the “4A” values at the heart of our culture: Aspiration, Ability, Agility and Accountability.


To help us deliver our medical image analysis solutions to large clinical trials we are hiring a Associate Data Manager on a permanent full-time capacity.


Purpose of the Role:


Working closely with the Project Manager and Science Lead, the Associate Clinical Data Manager will be responsible for data cleaning and transfer of clinical neuroimaging data on a varied portfolio of neurology clinical trials.


The Associate Clinical Data Manager will ensure the data management process on each new Project is setup, quality controlled, and managed robustly; meeting regularly with the Site Manager and Image Analyst to maintain oversight of this dataflow and support with issue resolutions, as and when they arise throughout the Project. The Associate Clinical Data Manager will be the escalation point and point of contact for the Sponsor and IXICO Project Manager on all data-related questions and is directly responsible for performing data checks/reconciliations, and execution of data and image transfers.


IXICO operates its own in-house Clinical Data Management (CDM) System called TrialTrackerTM along with cutting-edge Artificial Intelligence algorithms for analysing brain scans. IXICO’s processes are tailored for managing neuroimaging data and IXICO Clinical Data Managers have the opportunity to become specialised in handling neuroimaging data within a unique CDM system.


Essential Duties and Responsibilities:


The duties and responsibilities listed below are representative, but not exhaustive of the role. There may be some variation and/or development of these duties and responsibilities without changing the general nature of the role.


  • Performs data management activities, focusing on data cleaning and data transfer of imaging data sent through to IXICO for assigned projects.
  • Ensure the data cleaning and transfer processes on each new project is setup, quality controlled, and managed robustly.
  • Attend and participate in sponsor meetings as requested.
  • Act as the escalation point and point of contact for the Sponsor and IXICO project Manager on all data related questions.
  • Perform QC on all aspects of work performed in Site Management, Image Analysis and Data Management teams to ensure that data quality and integrity is maintained.
  • Run and perform routine ad hoc data cleaning checks on Project data, identifying errors, inconsistencies and discrepant data for resolution.
  • Track outstanding issues and following-up until resolution.
  • Maintain, organize, complete, and update study documentation, including writing Data Transfer Agreements and Image Transfer Agreements and configuring associated extracts for data transfer output.
  • Write project-specific transfer work instructions and perform test/production transfers.
  • Assist in standardising and documenting data management procedures.
  • Follow all IXICO data management (DM) procedures, policies, and work instructions.
  • Read, understand, and follow applicable Standard Operating Procedures (SOPs).


Qualifications and skills required for the role:


Essential

  • Bachelor’s degree in Computer Science, Life Sciences or related field preferred, or equivalent experience required.
  • 1+ years’ experience of working in data management within the Pharmaceutical, Biotech or CRO industry recommended.
  • Strong IT skills (working within cloud-based database systems desirable) and demonstrate experience of working with a variety of data formats.
  • Experience working with Microsoft Office tools including Word and in particular Excel.
  • Ability to learn other computer systems, including databases.
  • Strong attention to detail and excellent communication and interpersonal skills, both verbal and written.
  • Team oriented and flexible; ability to function in high volume environment with competing priorities.
  • Ability to perform multiple tasks simultaneously under direction and prioritise workload.
  • Ability to work independently in a group setting; ability to adjust to changing priorities.
  • Maintain a professional and positive attitude.


Desirable

  • SAS Experience.
  • SQL Experience.


Benefits

  • Competitive remuneration package including benchmarked salaries.
  • Staff Annual Bonus Plans and Annual Salary Review.
  • Generous employer pension contribution of 6%.
  • 25 days annual leave, increasing up to 28 days with every year at IXICO.
  • BUPA private medical insurance scheme.
  • Life Assurance of 4x annual salary.
  • Employee Benefits Portal, Perkbox offering various discounts in retail, food & drink, and entertainment.
  • Engaging and social environment, with fundraising and sporting activities and seasonal events such as Summer and Christmas parties.
  • Wellbeing initiatives such as eye tests, flu jabs, and Mental Health Awareness Training.
  • Employee Assistance Programme offering advice and support on a wide range of topics.
  • Hybrid working model pattern split between working at our vibrant head office in the City of London and remotely.
  • Reimbursement allowance to purchase equipment to support working from home.
  • Generous employee referral scheme offering £2,000 for referring a successful candidate to the company.
  • Financial assistance for professional qualifications.
  • A company in an industry where your work has an impact every single day.


How to Apply

IXICO is working hard to create a representative, inclusive and empowered team, because we believe different experiences, perspectives and backgrounds make a better workplace, and ultimately better services.


IXICO doesn’t discriminate on the basis of race, colour, religion or belief, gender, national origin, age, sexual orientation, marital status, disability or any other protected class.

This is a great opportunity for a motivated Associate Data Manager in a permanent full-time capacity to thrive in an engaging and fast-paced environment, to make a difference on an everyday basis.


If you think IXICO should meet you, please send us your CV and covering letter by email to or apply directly via LinkedIn . We are looking forward to your application.

Please note that our entire business is operating under a Hybrid-Working Model , where UK-based employees are required to attend our London office 2 days a week . If you have got any questions, please reach out to our careers team.


Please note that IXICO will process the data provided by you only in order to perform the outlined recruitment exercise. For more details on what data we process and on what legal basis this happens please view our Recruitment Privacy Policy or contact

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Remote Clinical Data Manager - Oncology Trials

NE1 4EP Newcastle upon Tyne, North East £65000 Annually WhatJobs

Posted 4 days ago

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full-time
Our client, a leading international contract research organization (CRO) specializing in oncology, is seeking a meticulous and experienced Remote Clinical Data Manager to support their groundbreaking clinical trials. This is a fully remote position, offering the opportunity to contribute to life-saving research from anywhere. You will be responsible for ensuring the quality, integrity, and completeness of clinical trial data collected from various sites globally. Your role involves database design and setup, data review and cleaning, query management, and ensuring compliance with regulatory standards (e.g., GCP, CDISC).

As a remote team member, you will collaborate closely with clinical research associates (CRAs), biostatisticians, and study physicians in a virtual setting. Excellent communication and organizational skills are crucial for effective remote teamwork. You will be proficient in clinical data management software and possess a strong understanding of clinical trial processes. The ideal candidate will have a keen eye for detail, a systematic approach to data handling, and a commitment to upholding the highest standards of data accuracy and regulatory compliance. Experience in oncology trials is highly desirable.

Key Responsibilities:
  • Oversee the end-to-end clinical data management process for oncology studies.
  • Design, build, and validate clinical databases (e.g., EDC systems) in accordance with study protocols and standards.
  • Develop data management plans (DMPs) and data review guidelines.
  • Execute data validation checks, identify data discrepancies, and generate/resolve data queries.
  • Perform SAE reconciliation and ensure timely reporting of serious adverse events.
  • Collaborate with clinical operations and medical teams to ensure data accuracy and completeness.
  • Manage database lock processes and ensure data integrity for statistical analysis.
  • Contribute to the development and maintenance of data management SOPs.
  • Ensure compliance with ICH-GCP guidelines and other relevant regulatory requirements.
  • Train and mentor junior data management staff as needed.

Qualifications:
  • Bachelor's degree in Life Sciences, Health Information Management, or a related field.
  • Minimum of 5 years of experience as a Clinical Data Manager in pharmaceutical or CRO settings.
  • Extensive experience with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical).
  • Strong understanding of CDISC standards (SDTM, ADaM) is essential.
  • Experience managing oncology clinical trials is highly preferred.
  • Proficiency in data analysis and reporting tools.
  • Excellent understanding of ICH-GCP and other relevant regulatory guidelines.
  • Exceptional attention to detail and organizational skills.
  • Strong written and verbal communication skills for effective remote collaboration.
  • Ability to work independently and manage multiple priorities in a remote setting.

This fully remote role, supporting our client's extensive research activities originating from their UK operations, particularly concerning studies linked to Newcastle upon Tyne, Tyne and Wear, UK , offers a competitive compensation package and the opportunity to make a significant impact in oncology clinical research.
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Clinical Data Manager (Data Review)

Bath, South West IQVIA

Posted 5 days ago

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The CDM will perform scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).
Deliverables:
- Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
- Provides scientific data review support for more than one low to moderate complexity trial or one high complexity trial.
- The data management expert who, within the therapeutic area, is performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). Tapping into technical and clinical expertise, closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when implementing the data management related activities for protocols, with focus on more complex indication and therapy related elements of the study. Reviews all necessary data flows, the Data Management Plans and performs continuous (complex) data review activities on the studies in the assigned program.
- Involved in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
- Reviews (complex) scientific study data, manages CDM and SRS/SRP related queries in eDC system and holds discussions with SRS/SRP. Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible. Leads and/or attends meetings as appropriate.
- Takes a leadership role with SRP/SRS and collaborates with the GDM to establish, align and confirm scientific clinical data review expectations for assigned trial(s).
- With the trial customer, CRO and other functional partners in relation to CDM related activities:
o Reviews content and integration requirements for eCRF and other data collection tools
o Establishes conventions and quality expectations for clinical data.
o Set timelines and follow‐up regularly to ensure delivery of all Clinical Data Management milestones
- Creates the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Reviews related clinical data management documents. Ensures compliance with regulatory guidelines and documentation requirements.
- Ensures real‐time inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and Client internal audits as necessary.
- Plans and tracks applicable CDM deliverables. Ensures CDM deliverables are on time.
- Takes a leadership role in collaborating with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are met.
- Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
- Identifies and participates in process, system, and tool improvement initiatives within clinical data management.
Therapeutic Area - Oncology, Cardiovascular and Immunology
**Education/Experience**
- BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure.
- 5 years Data management experience. Data Management experience preferably including clinical data review or significant experience with clinical data review. Knowledge in medical terminology would be preferable
- Collaboration with Clinical teams.
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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Remote Clinical Data Manager - Oncology

NG1 1AA Nottingham, East Midlands £45000 Annually WhatJobs

Posted 2 days ago

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full-time
Our client is seeking a meticulous and experienced Remote Clinical Data Manager to play a vital role in their oncology research programs. This fully remote position allows you to contribute significantly to groundbreaking clinical trials from the comfort of your own home, with a primary focus on the **Nottingham, Nottinghamshire, UK** region's patient data but managed globally. You will be responsible for the end-to-end management of clinical trial data, ensuring its accuracy, completeness, and compliance with regulatory standards (e.g., ICH-GCP, FDA). Key responsibilities include developing data management plans, designing electronic data capture (EDC) systems, setting up edit checks, managing data review processes, and overseeing database lock.

The ideal candidate will possess a Bachelor's or Master's degree in a relevant life science or health-related field, coupled with a minimum of 3-5 years of progressive experience in clinical data management within the pharmaceutical or biotechnology industry, specifically in oncology. Proficiency with EDC systems (e.g., Medidata Rave, Oracle Clinical) and a strong understanding of clinical trial processes are essential. You must be highly organised, detail-oriented, and capable of managing multiple projects simultaneously in a remote setting. Excellent communication skills are required to liaise effectively with internal teams (clinical operations, biostatistics, programming) and external vendors. This role demands a proactive approach to problem-solving and a commitment to maintaining data integrity and patient confidentiality. You will be instrumental in ensuring the successful execution of clinical trials by providing high-quality data that supports critical decision-making.
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Remote Senior Clinical Data Manager

B1 1 Birmingham, West Midlands £60000 Annually WhatJobs

Posted 2 days ago

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full-time
Our client, a forward-thinking pharmaceutical research organization, is seeking an experienced Senior Clinical Data Manager to join their global team on a fully remote basis. This vital position will play a key role in ensuring the accuracy, integrity, and completeness of clinical trial data, which is fundamental to the success of our drug development programs. The ideal candidate will have a robust understanding of clinical trial processes, data management principles, and relevant regulatory requirements (e.g., FDA, EMA). You will be responsible for developing data management plans, overseeing database design and validation, managing data cleaning activities, and ensuring timely database lock. This role is perfectly suited for a seasoned data professional who is highly organized, detail-oriented, and proficient in managing complex projects in a remote work environment.

Key Responsibilities:
  • Develop and implement comprehensive Clinical Data Management Plans (CDMPs).
  • Oversee the design, build, and validation of clinical databases using EDC systems.
  • Develop data validation specifications and perform data review and cleaning activities.
  • Manage query generation, resolution, and tracking to ensure data accuracy.
  • Lead the process for database lock, ensuring all data is complete and validated.
  • Ensure compliance with relevant regulatory guidelines (e.g., GCP, ICH, CDISC) and company SOPs.
  • Liaise with clinical operations, biostatistics, and programming teams to ensure seamless data flow.
  • Provide technical expertise and guidance to junior data managers and study team members.
  • Contribute to the development and maintenance of data management tools and processes.
  • Manage outsourced data management activities with CROs, as applicable.
This role is entirely remote, requiring strong analytical skills, excellent communication abilities, and a proven track record of working effectively in a distributed team. The successful candidate will be adept at utilizing electronic data capture (EDC) systems and other data management software. You will be instrumental in upholding the quality and integrity of clinical data that supports critical regulatory submissions and product approvals. This is an outstanding opportunity to advance your career in clinical data management with a leading pharmaceutical company that values innovation and collaboration, all while working remotely from Birmingham, West Midlands, UK .
The ideal candidate will possess a Bachelor's degree in a relevant scientific discipline (e.g., Health Informatics, Statistics, Computer Science) or equivalent experience. A minimum of 7 years of progressive experience in clinical data management within the pharmaceutical or biotechnology industry is required, with at least 2 years in a lead or senior role. Expertise with major EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva EDC) is essential. Proficiency in CDISC standards (SDTM, ADaM) is highly desirable. Strong understanding of GCP and regulatory requirements for clinical trials is mandatory. Excellent problem-solving, organizational, and project management skills are necessary. The ability to work independently, manage multiple studies concurrently, and meet tight deadlines in a remote environment is crucial. Exceptional communication skills, both written and verbal, are needed to collaborate effectively with global teams.
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Senior Clinical Data Manager - Hybrid, UK

Veramed

Posted 15 days ago

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An exciting opportunity to join Veramed's Data Management Business Unit! As we continue to grow and build on our success, we're looking to recruit a passionate and driven Senior Clinical Data Manager. You'll be required to have strong and indepth expereince of Data Management Study Start Up, Medidata Rave (including eCOA) and experience of vendor management. This role can be based in our UK offices or a hybrid working model.


Veramed prides itself on two key areas: providing the highest quality Data Management, Statistics and Programming consultancy for its clients, and giving its employees an industry leading working environment with support and training for career growth.


Purpose:

The role of the Senior Clinical Data Manager is to provide data management support to the data management department across a range of projects, sponsors and therapeutic areas. Provide expertise and manage the start up of new data management studies.


Key Responsibilities:

The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.


Technical:

  • Review of clinical protocols
  • Create or review Case Report Forms for data collection and compare with the protocol to ensure consistency
  • Create or review Edit Check Specification document
  • Preparation of UAT documentation and perform UAT of EDC and communication of findings
  • Creation of study specific documents such as Data Management Plan, Data Review Plan, eCRF Completion Guidelines, etc.
  • Create or review specifications for data review listings and / or customized reports to facilitate data cleaning
  • Ongoing review of data entered in EDC to ensure the data is clean for analysis
  • Issue queries to clinical monitors or investigational sites as appropriate
  • Resolve standard queries
  • Perform medical coding
  • Work with external vendors on data transfer agreements / specifications
  • Ensure external data is reconciled as required
  • Track queries and data cleaning activities to ensure ongoing review of data entered is completed and data is fit for analysis.
  • Maintain study master file documents and any other documents that are required to be audit ready
  • Work in accordance with internal (or sponsor, where applicable) SOPs and procedures


Project Management:

  • May serve as the main contact for the sponsor
  • Awareness of study budget and proactive identification of scope changes
  • Ensure key project milestones are delivered on time with the highest quality
  • Maintain timelines and communicate risks / updates to the Data Management Project Manager
  • Collaborate with cross-functional team members to ensure that the study deliverables are provided on time and with quality


General:

  • Lead internal and client study team meetings effectively
  • Present study updates internally and at sponsor meetings
  • Share scientific, technical and practical knowledge within the team and with colleagues
  • Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
  • Build effective collaborative working relationships with internal and sponsor team members
  • Seek opportunities to develop innovative ideas and sharing when appropriate
  • Mentorship of more junior team members
  • Contribution to development of internal training materials
  • Contribution to internal process improvement initiatives


Minimum Qualification Requirements

  • BSc or MSc in numerical discipline (or relevant equivalent industry experience).
  • At least 7 years of relevant industry experience.
  • Understanding of clinical drug development process, relevant disease areas, endpoints, and different study designs
  • Awareness of industry and project standards & ICH guidelines
  • Excellent verbal and written communication skills
  • Interpersonal/teamwork skills for effective interactions
  • Self-management skills with a focus on results for timely and accurate completion of competing deliverables
  • Demonstrated problem solving ability and attention to detail
  • Project leadership experience
  • Ability to make informed and appropriate decisions
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Associate Vice President, Clinical Data Management

Uxbridge, London Amgen

Posted 12 days ago

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Job Description

**JOIN AMGEN'S MISSION OF SERVING PATIENTS**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**ASSOCIATE VICE PRESIDENT, CLINICAL DATA MANAGEMENT**
**Live**
**What you will do**
The Associate Vice President, Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization.
**You will lead Amgen's Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development** **programs.** **This role is responsible for the strategic direction, leadership, and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases.**
You will collaborate closely with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and quality to drive data integrity and compliance with global regulatory standards.
The role requires a visionary leader with deep expertise in CDM and a proven ability to scale and lead global teams in a complex matrix environment.
**Responsibilities:**
+ **Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals.**
+ **Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases.**
+ **Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows.**
+ Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums.
+ Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance.
+ **Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization.**
+ Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues.
+ Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions.
+ Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics.
+ Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data.
+ Build and maintain strategic relationships with CROs, vendors, regulatory authorities, and industry organizations to advance CDM excellence.
+ Influence internal leadership and functional partners to promote data-driven decision-making across clinical programs.
+ Lead audit readiness efforts and promote a culture of continuous improvement and compliance within the CDM function.
+ Implement protocols and tools to ensure data security, integrity, and risk management across all platforms and studies.
+ Optimize staffing, outsourcing strategies, and technology investments to improve cost-efficiency, scalability, and delivery timelines.
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.
**Basic Qualifications:**
+ **Degree educated in relevant discipline**
+ **Extensive data management experience including managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources**
**Preferred Qualifications:**
+ Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment.
+ **Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM).**
+ Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen's global clinical development efforts.
+ Expertise in AI/ML-driven data management solutions, automation, and advanced analytics.
+ **Understanding of clinical data standards (CDISC, SDTM, ADaM).**
+ **Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions**
+ Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management.
+ Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams.
+ **Experience managing FSP relationships and technology implementations (EDC, CTMS, RWD/RWE).**
+ **Knowledge of emerging trends in digital health, data governance, and data privacy regulations (GDPR, HIPAA).**
+ Familiarity with decentralized trial models and digital health technologies.
The successful candidate will also embody the Amgen leadership attributes which are:
+ **Inspire:** Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
+ **Accelerate:** Enable speed that matches the urgency of patient needs by encouraging progress over perfection
+ **Integrate:** Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
+ **Adapt:** Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided 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 accommodation.
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