Priya Mukherjee at CK Clinical is currently looking for a Senior Clinical Data Manager to join a leading pharmaceutical company based in the South East of England.
Senior Clinical Data Manager Job Description:
As Senior Clinical Data Manager, you will be responsible for all Data Management activities, including data quality and the timely delivery of database locks for projects, particularly within the Oncology therapy area.
You will perform all DM activities (including set-up, managing the Data Management Plan (DMP), protocol review, CRF development, database set-up activities, data validation and query management, medical coding, and SAE reconciliation).
As Senior Clinical Data Manager you will also coordinate and manage data cuts and data cleaning necessary for interim analyses or to support Data Monitoring Committee (DMC) review. You will represent DM on global teams, coordinate activities of related functions and department as necessary to meet DM deliverables, manage studies conducted in-house or oversee activities of on-shore or off-shore CROs.
- Project management of all Data Management activities from start to finish
- DMP set-up and management, protocol review, CRF development, database set up activities, data validation, medical coding and SAE reconciliation
- Coordinate with the Programming team to provide support to the clinical teams (coordinate data retrieval and generation of data review listings)
- Coordinate with the Programming team to support DMC activities (coordinate the data cut and generation of listings as needed)
- Coordinate CRO data validation activities (query generation and resolution)
- Perform other data management, departmental activities as needed, including delivery of training as required
- Participate in the development and implementation of department standards and documents
Qualifications, Skills and Experience:
- To be considered for this Senior Clinical Data Manager, you will have the following qualifications, skills and experience:
- Interested applicants will hold a Bachelor degree in a Life Sciences discipline or other related field (OR Equivalent).
- You will also have proven experience in providing Data Management support for Oncology studies, setting up and management of EDC studies using either Inform or Clintrial and proven experience in handling local laboratory data.
- You will have thorough knowledge and understanding of GCP, the clinical research drug development process and the role of Data Management in clinical trials and proven experience in managing CROs, internal project teams and external vendors.
How to apply:
Please click here to apply online now.
For more information regarding this Senior Clinical Data Manager position, please contact Priya Mukherjee on +44(0)1438 870 028 or email firstname.lastname@example.org.