Role OverviewWe are looking for an experienced Associate Director, Clinical Data Management that will contribute to and support the company's research and development efforts to create high value therapeutics to address unmet medical needs. The Associate Director, Clinical Data Management independently leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs.
What You Will Do
Provide expertise and contribute to the strategy and development of the Clinical Data Management Portfolios to ensure data quality in support of clinical study data milestones and deliverables. Lead and support establishment of systems and processes to help ensure clinical data security, integrity, and long-term goals of the business function.
Why It Might Be a Fit
A minimum of 10+ years of Clinical Data Management experience (oncology experience highly desirable) in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required. Strong track record of line management and supervisory experience of CDM staff, shown leadership skills to lead and inspire CDM staff including consultants.
Requirements
- Bachelor’s degree in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience
- A minimum of 10+ years of Clinical Data Management experience (oncology experience highly desirable) in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required
- Experience with various data collection and Electronic Data Capture (EDC) systems and understanding of the MedDRA and WHODRUG coding processes
- Strong track record of line management and supervisory experience of CDM staff, shown leadership skills to lead and inspire CDM staff including consultants
- Excellent interpersonal, communication, and leadership skills
- Consistent, detail oriented, communicative, dedicated to do a job well done
- CRO and vendor oversight experience preferred
- Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
Benefits
- Dental insurance
- Vision insurance
- Bonus
- Stock
- Benefits
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