Lead Data Manager

PSI CRO; Oxford; On-site; GBP 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Lead Data Manager to oversee data management in complex clinical studies. This role involves coordinating data activities, ensuring quality control, and training team members. With a focus on communication and organizational skills, you will be the primary contact for project teams and clients, driving the success of data management initiatives. Join a dynamic global company dedicated to advancing medical science and making a real difference in patients' lives. This is an exciting opportunity to grow your career in clinical research and contribute to impactful projects.

Qualifications

• 3+ years of data management experience in international EDC studies.
• Experience with CDM/EDC systems is essential.

Responsibilities

• Coordinate data management activities in clinical projects.
• Perform database QC checks and manage audit follow-ups.

Skills

Data Management

Communication

Organizational Skills

Quality Control

Training

Education

College or University degree

Tools

CDM/EDC systems (MedidataRave, Oracle Inform)

Job description

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 Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects.

Communication

• Primary communication point for project teams and company departments with regard to clinical data management.
• 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:
• Study documents review
• Data Management plan and other project-specific guidelines and instructions development and review
• Co-ordinate/perform user acceptance testing
• Development of Data Validation Plan/Edit Check Specifications
• Data entry coordination and supervision, feedback to data entry personnel regarding quality of data entry and other data entry issues
• Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data
• Non-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues)
• Database edits (paper CRF studies)
• Manual CRF review (non-medical checks)
• 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).
• SAE reconciliation.
• Electronic data transfer (import/export) specifications review and approval.

Document Management

• Liaison with Document Center with regard to maintenance of TMF and eTMF.

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 of Assistant Data Managers.
• Project-specific training of investigators and clinical team in CRF completion.

Corporate/Departmental Assignments

• Investigator Meetings preparation/attendance.
• Meetings and teleconferences organized by client/vendor preparation/attendance.

Qualifications

• College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities.
• At least 3 years of experience of full scope of data management responsibilities in international EDC studies.
• At least 2 years of experience using CDM/EDC systems (MedidataRave or Oracle Inform preferable).
• Project data management experience is a plus.
• Organizational and managerial skills.

Additional Information

Advance your career in clinical research and develop new skillsets whilst growing with the organization.