Associate Director, Clinical Data Management

The role

The Associate Director, Clinical Data Management leads data management components for clinical trials ranging from small early phase to large global and late phase programs. This role directs the planning, implementation, and execution of clinical trial data management activities and manages data management staff, CROs, and service providers.

What you will do

• Provide expertise and contribute to the strategy and development of the Clinical Data Management Portfolios
• Lead and support establishment of systems and processes for clinical data security and integrity
• Leads the data management of overall drug development process with early and late phase clinical trials
• Develop and implement clinical data standards, data management plans, data transfer agreements, and data flow processes
• Oversees the process to identify, evaluate and select CROs, vendors and technology
• Leads, designs and/or oversees eCRF design, specifications, completion guidelines, annotated CRFs, UAT, query logic, edit checks, and database closeout
• Represents Data Management and promotes collaboration with other functions
• Supports cross functional teams to handle data management questions, troubleshoot, and mitigate risks
• Works with the Director of Clinical Data Science to enhance efficiency, optimize costs, and drive excellence
• Leads clinical data management activities during regulatory audits

Required qualifications

• 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 in biotechnology or pharmaceutical industry
• Excellent understanding of late phase clinical drug development processes
• Experience with various data collection and Electronic Data Capture (EDC) systems
• Understanding of the MedDRA and WHODRUG coding processes
• Strong track record of line management and supervisory experience of CDM staff
• Excellent interpersonal, communication, and leadership skills
• Consistent, detail oriented, communicative, dedicated to do a job well done
• Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements

Nice to have

• oncology experience highly desirable
• CRO and vendor oversight experience preferred

Benefits

• bonus
• stock
• benefits

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.