Reporting to the Head of Data Management, the Senior Manager of Clinical Data Management will lead data management activities in support of ADCT studies across all stages of clinical drug development. They will ensure that clinical data capture, systems and processes will ensure accurate, consistent, high quality, and complete data.
The candidate will provide clinical data management oversight of outsourced clinical trials including but not limited to project management, vendor management, coordination of internal reviews, and approval of deliverables. The candidate will impact multiple clinical development programs, health authority submissions, presentations and publications across internal and external stakeholders.
The Senior Manager, Clinical Data Management can be based remotely (East Coast preferred)
- Plan, coordinate, and manage data management tasks and timelines.
- Act as primary liaison with CROs, third party data vendors, and EDC vendors.
- Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed.
- Primary author/approver for CRFs, CCGs, edit check specifications, SAE reconciliation plans, Coding plans, Data Management Plans, and third-party vendor data specifications.
- Oversee clinical database design, production and UAT cycles, ensuring that the CRO meets the highest quality standards.
- Accountable for external data vendor documentation, management, and reconciliation.
- Contribute to departmental SOP and process development and improvement, and integration of technology.
- Perform and/or review medical coding and SAE reconciliation.
- Lead, facilitate, and conduct internal DM and cross functional review of clinical data.
- Support GCP inspection readiness.
Who You Are:
- Bachelor’s degree in a scientific discipline or equivalent.
- Master’s degree in a scientific discipline or equivalent preferred.
- 5+ years of clinical data management experience in pharmaceutical and/or CRO.
- Demonstrated proficiency managing the lifecycle of clinical data projects.
- Experience developing reports using J-Review, BOXI, and/or other CDM reporting tools.
- Proficient in Electronic Data Capture (EDC) systems such as Medidata Rave or other related DM systems.
- Experienced with CDISC standards (eg, CDASH, SDTM) and medical coding dictionaries (eg, MedDRA, WHO Drug).
- Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Management.
- Able o manage multiple initiatives and shifting priorities within a small company environment.
- Strong analytical and problem-solving skills that meet or improve the status quo.
- Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
- Excellent written and oral communication skills.