Associate Director, Clinical Data Management

Location
San Francisco, CA, United States
Posted
Sep 11, 2019
Ref
574
Discipline
Clinical, Clinical Data
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
ASSOCIATE DIRECTOR, CLINICAL DATA MANAGEMENT

Position Summary:

The Associate Director of Clinical Data Management (CDM) reports to the Senior Director of CDM. She/he will oversee all aspects of clinical data management activities for assigned clinical studies at GBT, from study start up to database lock. You will work closely with internal partners on the study team and functional counterparts at Clinical Research Organizations (CROs) and other service providers to ensure the successful execution of clinical studies in support of clinical development efforts to address unmet medical needs.

Essential Duties and Responsibilities:
  • Leads CDM activities for assigned clinical studies, including CRF/eCRF design, database development and validation, discrepancy and issue resolution, SAE reconciliation, EDC and non-CRF data reconciliation
  • Represents CDM on the Study Execution Team
  • Coordinates with partner functions and counterparts at CROs, central laboratories, and other service providers to ensure study objectives and CDM timelines are met
  • Leads CDM vendor and technology evaluation, selection, and qualification activities
  • Assists in CDM budget assessment and contract negotiations
  • Participate in the design, implementation, and improvement of internal CDM processes, standard operation procedures and work instructions
  • May train and/or supervise junior staff as needed

Qualifications:
  • Bachelor's degree in life sciences, mathematics or other quantitative fields
  • At least 10 years of experience in Clinical Data Management and a minimum of 4 years prior management experience of external vendors
  • Previous CDISC experience is required
  • Thorough knowledge of ICH and health authority guidelines
  • Demonstrated proficiency in data management processes
  • Working knowledge of global clinical studies
  • Proficient in the use of clinical data management systems
  • Excellent communication and collaboration skills
  • Less than 10% travel is expected

Fit with GBT culture:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.