Careers

Senior Manager/Associate Director, Clinical Data Management

The Senior Manager/Associate Director of Clinical Data Management will be responsible for leading and managing the data management activities for several clinical trials. This role works closely with the CRO Data Managers to ensure on-time seamless delivery of quality Data Management tasks independently and ensure that studies are properly designed, run, presented and reported.   This position reports to the Director, Data Management, and is primarily remote, however, will require working closely with a cross-functional team based in the San Francisco Bay area. Some travel to the Burlingame, CA office may be required.

Essential Responsibilities

• Lead and oversee all data management activities for multiple clinical trials, including but not limited to design and completion guidelines for eCRF, design and testing of EDC systems, development of edit checks, development of data management plan, development of data transfer agreement, SAE reconciliation, database freeze and lock activities
• Oversee CRO’s activities to ensure the quality of deliverables and that timelines are met
• Ensure that the CDM related documentation required to support regulatory submissions and inspections are maintained to the standard required
• Collaborate closely with clinical operation, clinical science, biostatistics, statistical programming, drug safety, and regulatory to ensure operational excellence
• Participate in the generation and approval of budgets and timelines
• Participate in the development, review and implementation of processes, SOPs, and standard templates for clinical data management (CDM)
• Provide direction and leadership in CRO and vendor selection and management
• Recognize potential CRO performance issues and escalate them effectively for resolution

Required/Preferred Education, Skills, and Qualifications

• BA/BS or higher education
• 6+ years of experience in CDM in biotechnology or pharmaceutical industry
• Hands-on experience with mainstream EDC systems (e.g. Medidata RAVE, Inform, etc)
• Solid understanding of CDASH and CDISC standard
• Extensive experience managing CROs
• 3+ years of direct Oncology experience in solid tumor is required
• Experience with pivotal clinical trials conducted globally in successful NDA/BLA submission is preferred
• Thorough knowledge of clinical data management and its role in the drug development process
• Solid understanding of ICH/GCP guidelines as they relate to clinical data management
• Ability to prioritize and handle multiple tasks simultaneously
• Excellent communication/interaction skills and ability to work with a global multicultural team
• Accountable and proactive
• Ability to self-motivate and work independently with a no-job-too big or too small attitude, who thrives in a fast-paced and energetic environment