Associate Director, Data Management

Job Description
The Associate Director of Data Management (DM) will act as the lead of one or several programs with accountability for all DM activities in Bicycle clinical studies including study set-up, capture/review/clean/delivery of clinical data and close-out. The Associate director of Data Management is responsible for timely and high-quality data management deliverables supporting the Bicycle Portfolio. The Associate Director of Data Management will report to the Director of Data Management.
The ideal candidate has a demonstrated strong expertise in Clinical Data Management, advanced working experience on clinical studies in Oncology therapeutic area, as well as contributing to influential leadership on DM activities to support clinical development, regulatory submissions, and inspections.
Responsible for all DM deliverables as the program lead in multi-disciplinary interactions
Provides strong quality and project oversight over third party vendor
Responsible for data management deliverables by closely monitor data quality, timeline and actively identify and mitigate risks
Efficiently plans, coordinates, and delivers complete high quality and reliable clinical trial data
Responsible for end-to-end clinical data management activities including integration requirements (Oversee the design, building, testing and maintenance of clinical study database as well as oversight of data finalization and database lock activities)
Represent Data Management on cross-functional project teams and submission teams.
Serve as in house DM point of contact at program level, in all interactions with vendors, provide review and approval for both DM functional documents and other relevant study documents as needed. Provides oversight vendor DM work to ensure high quality
Participates to best practices initiatives, identify the need, and participates to the creation of functional standard operating procedures and Work Instructions for DM function