The Senior Data Manager oversees data management in complex clinical studies, ensuring communication with clients and vendors, coordinating data management activities, conducting quality control checks, training junior staff, and managing data integrity in various projects.
Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
The Senior Data Manager will be responsible for oversight of all data management activities in large, complex studies.
Communication
- Provide general oversight on all Data Management activities on large complex global studies
- Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting
Data Management
- Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables.
- Primary responsibility for clinical data management activities within clinical projects, including, but not limited to:
- Reviews and approvals, escalation point and troubleshooting
- Involved in audits and inspections
- Supporting with SOP development and process improvements
- Provide input into Proposals, Budgets and Bid Defense meetings
- Clinical database lock
- Coordination and supervision of processing, dispatch and archiving of CRFs/queries
- Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
- Development of CRF completion guidelines
- Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)
- Electronic data transfer (import/export) specifications review and approval
Quality Control
- Database QC checks performance and documentation
- Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management
- Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management
Training
- Training junior members of the team
- Project-specific training of investigators and clinical team in CRF completion
Qualifications
- College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
- Significant experience of full scope of data management responsibilities in international EDC studies
- Experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
- Organizational and managerial skills
Additional Information
Advance your career in clinical research and develop new skillsets whilst growing with the organization.
Top Skills
Medidata Rave
Oracle Inform
Similar Jobs
Be an Early Applicant
The Data Senior Manager, Growth is responsible for leveraging data to drive growth strategies and optimize decision-making. Key responsibilities include developing attribution models, calculating channel-level CACs, designing experiments, and creating dashboards that provide insights into growth performance.
Be an Early Applicant
The Senior Data Product Manager will lead Ozone's data products by overseeing the data product roadmap, managing the product development lifecycle, and collaborating with various teams to implement data experiments and translate findings into product features.
Be an Early Applicant
The Data Platform Domain Lead will define and execute the data platform strategy, ensuring it aligns with the overall goals of Petcare. This role involves leading the delivery of platform capabilities, managing cross-functional teams, and optimizing use of data resources while monitoring key performance indicators. Strong stakeholder collaboration and governance will be key to success in this role.
What you need to know about the London Tech Scene
London isn't just a hub for established businesses; it's also a nursery for innovation. Boasting one of the most recognized fintech ecosystems in Europe, attracting billions in investments each year, London's success has made it a go-to destination for startups looking to make their mark. Top U.K. companies like Hoptin, Moneybox and Marshmallow have already made the city their base — yet fintech is just the beginning. From healthtech to renewable energy to cybersecurity and beyond, the city's startups are breaking new ground across a range of industries.
