Director of Data Management
QED is a subsidiary of BridgeBio and focuses on finding and developing drugs for genetic diseases to provide new cures for patients in need. Our team partners with academia and pharma to identify the right assets based on our systematic mapping of the genetic disease landscape, and develops those assets with a highly targeted approach that supports R&D with expert capabilities and places each program in a value maximizing corporate structure that balances risk and reward for partners.
The Director of Clinical Data Management, is responsible for managing all clinical data management activities according to quality standards, ICH guidelines, GCP and regulatory requirements. The person will report to the Head of Biostatistics and Data Management.
Essential Skills & Functions:
- Represent clinical data management in meetings with internal cross-functional teams, external vendors and regulatory agencies
- Collaborate with internal cross-functional team and vendor to ensure timely transfer of database with high quality.
- Oversee and participate in all data management activities for multiple clinical development programs, such as vendor evaluation, database transfer, CRF development, database specifications, user acceptance testing, query resolution, data review and data base lock
- Create thorough data quality checks and data review strategies to ensure the integrity of the clinical data
- Manage reconciliations between clinical and safety databases.
- Contributes to development of outsourcing strategies and relationships with outsourcing partners or CROs
- Budget assessment and contract negotiations, training and oversight for all DM services from study start-up through study close-out and final reporting.
- Responsible for managing and tracking work orders associated with clinical DM activities to ensure that the operating costs for the DM department are achieved within budget.
- Possesses excellent interpersonal communication skills (written and verbal).
- Strong attention to detail.
- Previous CDSIC experience is desired.
- Proficient in the use of the clinical data management systems (e.g. Oracle clinical and/or Rave).
- Oncology experience is preferred.
- Complex and/or international trials experience.
Preferred Education and Experience:
- Education & Experience Required: Bachelor’s Degree in related field, or an equivalent combination of education and work experience. 10 years’ experience in Clinical Data Management at a CRO, biotechnology, or pharmaceutical company; and minimum of 4 years’ prior management experience.