In this leadership position, the Senior Director, Clinical Data Management will manage operational aspects of data management supporting global drug development activities. This position will drive the strategy and lead clinical data management initiatives across multiple therapeutic portfolios, as well as manage the selection and oversight of data management vendor partners. The successful candidate will provide leadership and guidance to the Clinical Data Management department, and will be responsible for supporting end-to-end data management activities, including the development and implementation of data standards based on CDASH/SDTM.
The Senior Director will be a key member of the Biometrics Development Leadership Team. This role will report to the Vice President of Biometrics.
- Establish and provide leadership to the Global Data Management team at BeiGene to set a culture of excellence and high performance.
- Ensure quality processes for data management through SOPs, training, and internal and external inspection activities.
- Provide expertise and guidance to the Clinical Development Team regarding CDASH and CDISC data standards.
- Provide data management representation and leadership on internal cross-functional teams, in addition to regulatory agencies.
- Work collaboratively with internal and external team members to coordinate the planning and execution of day to day data management deliverables.
- Establish best in class processes and standards for the generation and reporting of data.
- Build and lead a team of high performing clinical data managers to meet corporate regulatory, scientific, and business objectives.
- Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives.
- Lead development of department SOPs.
- Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines.
- Contribute to project budget/resource planning, re-forecasting, and program milestones.
- 10+ years of experience in clinical data management in the pharmaceutical industry
- Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Outstanding verbal and written communication skills, in addition to excellent organizational skills
- Creative, capable problem-solver
- Experience in regulatory GCP inspections/audits
- Early and late development experience
- Vendor management and oversight experience
- Strong technical skills across data platforms, Medidata Rave preferred
- Prior successful NDA and IND filing experience required
- Adept at outsourcing and managing services provided by clinical data management vendors and contractors.
- Extensive experience interacting with regulatory agencies, both US and ex-US.
- Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development.
- Bachelor’s degree in a science-based subject
Preferred Additional Skills:
- Excellent interpersonal and communication skills, both verbal and written.
- Consummate team player with excellent collaboration skills.
- Ability to communicate technical information to non-scientists, and willingness to educate internal team.
- Strong customer orientated awareness and focus; strives to support others to succeed.
- Pronounced quality focus.
- Strong leadership skills with ability to influence decisions and achieve results.
- Ability to adjust to multiple demands, shifting priorities, and unexpected events while maintaining a positive work attitude.