Director, Clinical Data Management (Biometrics)

Location
San Diego, CA
Posted
Jan 07, 2022
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Job Summary:

The Director, Clinical Data Management will be an integral member of the Biometrics team whose work enables the company to meet defined goals for the clinical development programs.  The incumbent collaborates with other functional peer groups at various management levels and senior management to ensure proper conduct and timely completion of all projects, as applicable. The successful candidate will report to the Head of Biometrics.

Role and Responsibilities (include but not limited to):

  • Lead a team of high performing clinical data managers to meet business objectives
  • Oversee all data management activities and deliverables
  • Act as core member of the study team and provides CRO oversight for end-to-end Data Management activities, and monitor DM deliverables
  • Participate in cross-functional team meetings and communicate regarding project status/issues and timelines (including study database lock and data reviews)
  • Oversee the development of data management documents (e.g., Data Management Plans, edit checks, data validation specifications, data transfer agreements)
  • Support the development of the clinical components of regulatory submissions
  • Perform data review, and lead internal cross-functional team review on clinical data in ongoing basis per Data Review Plan
  • Develop Vendor Management Plans, monitor vendors’ quality performance based on pre-defined quantitative or qualitative metrics
  • Manage competing data management priorities across multiple studies
  • Develop and maintain appropriate data management SOPs

Qualifications:

  • Excellent communication skills (oral and written) and interpersonal skills
  • Strong analytical and problem-solving skills

Job Requirements and Education:

  • Bachelor’s degree in Life Science, mathematics, or health-related fields
  • Minimum of 12 years data management experience in pharmaceutical/biotech/CRO industry
  • At least 2 years of oncology therapeutic area experience
  • Experience supporting eCTD submissions required
  • Strong working knowledge of GCP, CDISC/CDASH data structures, ICH guidelines and FDA regulations