Senior Clinical Data Manager

Senior Data Manager (Europe) Part Time

• Job Title: Senior Data Manager
• Experience: 8-10 years (flexible)
• Background and skills: CRO oversight experience with the following responsibilities (but not limited to): review of CRF, DMP, DVP, External Data Agreements, perform UAT, monitor data quality, define and monitor timelines, monitor CRO’s performance etc
• FTE 0.5 with flexibility, could be increased
• Contract duration: 1 year (Jan – Dec 2023, possibility of renewal)
• Start date: Jan 2023, at earliest availability
• Salary: €55-65/Hour
• Location: Central or Eastern Europe – very limited travel required, close to zero

Primary Duties + Responsibility:

·      Lead studies as the Lead Clinical Data Manager; liaise between study personnel and the client, as appropriate, regarding clinical and/or technical issues. May also serve as support for other Lead Clinical Data Managers as needed.

·      May serve as Program Data Manager for clients with multiple studies – will ensure consistency and efficiency across the board for database design elements, document development, and data trends/discrepancies. Oversees individual leads within the program and may contribute to employee development initiatives as a result.

·      Develop and/or review case report forms (CRFs) within an EDC system and build relevant database structure.

·      Develop or quality control review Data Validation Specifications (DVS) documents, program edit checks and other system functions within EDC as needed and facilitate or participate in User Acceptance Testing (UAT) prior to study go-live.

·      Author or perform quality control review of data management documents, such as CRF Completion Guidelines (CCGs), Data Management Plans (DMP), and Data Transfer Plans.

·      Responsible for data cleaning activities including data review, query generation and management, and development of study metrics either through direct action or delegation to other team members. May find discrepancies, track trends, and identify areas of retraining needed from members of the study team.

·      Responsible for the handling and reconciliation activities of external data (e.g., Central Labs, IVRS, etc.).

·      Oversee or participate in database lock activities, including managing user access and authoring or providing quality control review of lock documentation.

·      Perform quality control activities on projects across the department providing feedback to necessary individuals and working with them to correct any issues.

·    Partner with other functional groups (e.g., Biostatistics, Statistical Programming, Medical Writing, Project Management, etc.) to ensure data management aspects of the project are properly considered and will integrate well with the other activities.

·     May lead trainings and/or department initiatives to advance team’s understanding of these areas and/or improve related processes; may also serve as an internal representative for Data Management to effectively educate other departments as needed.

·      May serve as a technical lead in a specific area across projects within the department (e.g., Coding Expert).

·      Serve in a Project Management capacity as deemed necessary and appropriate.

·      Provide mentorship and/or training opportunities for junior level staff within the Data Management department.

·      Play an active role in business development activities, such as bid defenses and capabilities presentations as the Data Management Team representative, and/or participate in scoping out DM estimates for new Requests for Proposals.

·      Participate in activities related to inspection-readiness, including representing the Data Management group at audits (internal and external).

·      Lead strategic consulting efforts on behalf of the Data Management team.

To find out more contact me via camking@actalentservices.com

Job Title: Senior Clinical Data Manager

Location: Munich, Germany

Job Type: Contract

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