Job Summary
The Principal Clinical Data Manager (PCDM) leads the data management components of clinical trials with demonstrated subject matter expertise in all aspects of the Data Management (DM) discipline. The CDM is responsible for ensuring study launch, conduct, and closeout are performed according to company quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations.
Job Details
- Maintain effective communication with vendors and client's internal project team through oral and written correspondence, project status and progress reports.
- Manage the interaction with data management vendors to ensure that data management tasks remain on target according. TheseDM tasks include but are not limited to:
- protocol review to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within scope Ensure the accurate development of CRFs and edit specification per protocol and the completeness of user acceptance testing of CRFs and associated edit specifications for assigned clinical trials
- Provide ongoing operational oversight and support for Electronic Database Capture system activities during clinical trial conduct including development of clinical databases and associated external data transfer documents including import/export agreements and data specifications
- Provide ad-hoc report development, and support database lock and archiving activities.
- Oversight and management of cross-functional collaboration, development, and maintenance of all CDM documentation components, i.e., the study Data Management Plan (DMP) and data management deliverables including the Electronic Case Report Form (eCRF), eCRF completion guidelines, annotated CRFs, data handling plan, data review plan, edit check specifications, data transfer specifications, data quality plan, Interim/Final database lock list/approval, etc
Requirements
- Education preferences or requirements - Minimum of Bachelor's Degree in science or health related area required
- Minimum of 10 year's data management experience in pharmaceutical or biotechnology; prior oncology experience required
- Experience with multiple Electronic Data Capture (EDC) process and platforms such as Medidata RAVE, Medrio, etc
- Demonstrated proficiency with ICH, GCDMP, and GCP is required
- Previous experience managing/oversight of CRO vendors
* This position is fully remote with no requirement to relocate after the pandemic.
