Biotechnology client is seeking a Sr. Clinical Data Manager . The Senior Clinical Data Manager to lead Clinical Data Management activities for assigned Oncology clinical studies ( Phase I-IV)
6 + years of CDM experience required .
Key Responsibilities
- Act as Lead Clinical Data Manager in collaboration with CRO Data Management Lead
- Oversee the work of the outsourced CDM vendor for assigned projects.
- Review vendor deliverables for quality and timeliness, including oversight of external data transfers and deliverables in support of data review and reconciliation.
- Work with other functions to develop timelines, forecast resources required and ensure that deadlines are met.
- Participates as an active member of cross functional clinical study teams, program level teams, submission teams and provide expert guidance on CDM, CDISC and data quality.
- Plan and oversee development and testing of clinical data systems, including eCRF design, data review / validation specifications and other clinical data systems.
- Ensure the activities described in the Data Management Plan (DMP) are executed in accordance with the DMP, including data acquisition, data transfer, data reconciliation and review, medical coding, data extract and rolling data freeze, data lock and database lock.
- Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy.
Required Qualifications
- Bachelors or Master's degree, plus 5+ years of experience
- Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA / CFR, ICH / GCP)
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