Position : Associate Director, Clinical Data Management
Job Type : Hybrid, Full-time
Level : Mid-Senior level
Industry : Biotechnology / Pharmaceuticals
Overview : A biotechnology company is seeking an Associate Director of Clinical Data Management. The company focuses on discovering novel drug targets and delivering precision medicine for cancer treatment.
The role involves leading clinical data management processes across clinical trials, from trial planning to database lock, including oversight of vendors, data transfers, and ensuring high-quality data management practices.
Key Responsibilities :
- Manage the clinical data management partnership with CROs for clinical trials.
- Oversee outsourced clinical data management activities from RFP to final database lock.
- Develop and standardize data handling plans, data transfer specifications, and data review tools.
- Draft and manage database design, edit checks, and Data Management Plans for in-house data management activities.
- Collaborate with cross-functional teams and external partners (CROs, software vendors, etc.) to ensure project timelines are met within budget.
- Attend study team meetings to provide updates on data collection and issue resolution.
- Support the creation and configuration of eCRF libraries and database builds.
Qualifications :
- Bachelor’s degree in computer science or a related science-based field.
- Minimum of 8 years of clinical data management experience in the industry, with experience across multiple indications and EDC platforms.
- At least 3 years of management experience, preferably in a clinical research environment with a focus on oncology.
- Strong experience in vendor management and oversight.
- Proficiency in clinical trial design utilizing CDASH and SDTM standards.
- Understanding of FDA and ICH GCP guidelines for clinical trial data reporting.
- Experience with regulatory GCP inspections / audits preferred.
- Technical skills with data platforms, and programming experience is a plus.
- Familiarity with data visualization software such as Spotfire, Eluminate, or similar tools.
The company values diversity and does not discriminate based on race, gender, age, or other protected statuses.
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