Manager, Clinical Data Management

Location
San Francisco, CA, United States
Posted
Nov 14, 2020
Ref
908
Discipline
Clinical, Clinical Data
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
MANAGER, CLINICAL DATA MANAGEMENT

Position Summary:

The Manager, Clinical Data Management will support the clinical data management function at GBT. Reporting to the or Senior Manager, Clinical Data Management, they will work closely with Biometrics, Clinical Operations, Clinical Science, and Safety teams to ensure data quality of GBTs clinical trials. As an individual contributor, the successful candidate will be a strong hands-on executor as well as a strategic manager of internal and external partners. This individual is expected to engage with an ownership mindset. Local Bay Area candidates are preferred.

Essential Duties and Responsibilities:
  • Provide CDM leadership for assigned clinical studies, including overseeing and performing activities related to CRF design, database development, user acceptance testing, CRF Completion Guidelines, Data Management Plans, discrepancy and issue resolution, SAE reconciliation, EDC and non-CRF data reconciliation, providing metrics, and conduct the internal study team data review
  • Manage vendor partnerships
  • Collaborate with study team and vendor partners to ensure data quality and integrity
  • Coordinate with partner functions and counterparts at CROs, central laboratories, and other service providers to ensure study objectives and CDM timelines are met
  • Represent CDM on the Study Team
  • Ensure GBT data standards are incorporated into study builds
  • Participate in CDM vendor and technology evaluation, selection, and qualification activities.
  • Assist in CDM budget assessment and contract negotiations
  • Review vendor invoices
  • Participate in the design, implementation, and improvement of internal CDM standard operation procedures and work instructions
  • Work with the Study Team to set study goals and objectives
  • Accountable for maintaining a high level of data quality by adhering to corporate, industry and regulatory agency standards

Qualifications:
  • Bachelor's degree required, in health-related science, computer science, or equivalent preferred
  • At least 6 years of experience in Clinical Data Management and a minimum of 2 years prior management experience of external vendors
  • Working knowledge of global clinical trials
  • Thorough knowledge of applicable regulatory rules and ICH guidelines
  • Demonstrated proficiency in data management processes
  • Strong attention to detail
  • CDISC experience is required
  • Strong understanding of clinical data management systems (e.g. Medidata Rave, InForm) and experienced in the use of other data collection systems (e.g., ePRO, IRT, wearables)
  • Certified Clinical Data Manager, CCDM, accreditation a plus

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.