Associate Director, Study Data Manager
Core
Provide leadership for Clinical Data Management (CDM) delivery across oncology studies, overseeing data quality through external partners or internal teams and coaching junior colleagues.
Role type
Associate Director, Study Data Manager
Builds
High-quality clinical data for oncology therapeutic area studies
Domain
Life Sciences / Clinical Trials / Oncology
Required skills
Clinical Data Management (CDM), GCP, GDMP, medical terminology, SDTM, CDASH, database structures, CRF design, vendor management, risk management, strategic planning, budget management
Preferred skills
SQL, 4GL, VBA, R, leading Phase III trials, team management
Technologies
SDTM, CDASH, SQL, 4GL, VBA, R
Responsibilities
Provide training and coaching to junior colleagues; Represent CDM at cross-functional forums; Liaise with Clinical Quality Assurance for regulatory inspections; Manage vendor contracts, resourcing, and budget; Proactively manage risk and issue resolution; Ensure consistency of CDM processes and documentation across projects; Provide expertise on external service providers and in-house teams.
Seniority
Senior, hands-on IC with management responsibilities