The Associate Director/Director, Clinical Data Management assists the Senior Director, Clinical Data Management with data management activities in support of Sumitomo Dainippon Pharma Oncology studies across all stages of clinical drug development. The incumbent ensures that clinical data capture, systems, and processes represent accurate, consistent, high quality, and complete data. Additionally, the incumbent impacts multiple clinical development programs, health authority submissions, presentations, and publications across internal and external stakeholders.
- Provides clinical data management oversight of outsourced clinical trials for phase I-IV studies including: project management, vendor management, coordination of internal reviews, and approval of deliverables.
- Act as liaison with CROs, third party data vendors, and EDC vendors.
- Collaborates with internal clinical study team to ensure all stakeholders’ needs are addressed.
- Assist as author/reviewer for CRFs/eCRFs, CCGs/eCCGs, and Data Management Plans, as well as mentoring junior staff in these activities.
- Oversees database design and production, ensuring that CROs, vendors and internal staff meet the highest quality standards.
- Oversees report specification development including patient profiles and other reports, listings and metrics supporting clinical development decisions, periodic regulatory filings and study oversight.
- Accountable for external data vendor documentation, management, and reconciliation.
- Assist Sr. Director with oversight and management and mentoring responsibilities for contracted staff.
- Contributes to the strategic oversite of clinical programs and individual BBI sponsored trials.
- Contributes to departmental process improvement, standards and integration of technology.
- Other duties as assigned.
- Bachelor’s Degree required.
- 10-12 years of clinical data management experience in the pharmaceutical industry, with increasing responsibility.
- Demonstrated proficiency managing the lifecycle of clinical data projects.
- Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes.
- Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Management.
- Experience with drug development in oncology required.
Job Location: Cambridge, MA
Equal Opportunity Employer
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