Senior Manager, Clinical Data Management

Location
San Francisco, CA, United States
Posted
Apr 16, 2021
Ref
1037
Discipline
Clinical, Clinical Data
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
SENIOR MANAGER, CLINICAL DATA MANAGEMENT

Position Summary:

The Senior Manager, Clinical Data Management will manage related study activities across multiple studies or at a program level the clinical data management function at GBT. Reporting to the Senior Director, Clinical Data Management, they will work closely with Biometrics, Clinical Operations, Clinical Science, Safety, and Medical Affair 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.

Essential Duties and Responsibilities:

  • Provide CDM leadership and exercise judgement in the conduct of CDM responsibilities
  • Manage and organize CDM activities at a multi-study or program level
  • Serve as a CDM expert and provide input and oversight during all phases of a study 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 and monitor performance
  • 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
  • Ensure GBT data standards are utilized and maintained across studies
  • Conduct CDM vendor and technology evaluation, selection, and qualification activities
  • Perform CDM budget assessments and contract negotiations
  • Review vendor invoices
  • Develop update, and implement internal CDM standard operation procedures and work instructions
  • Work with Study Teams to set study goals and objectives
  • Accountable for maintaining a high level of data quality by adhering to corporate, industry and regulatory agency standards
  • Train and develop any direct reports


Qualifications:

  • Bachelor's degree required, in health-related science, computer science, or equivalent preferred
  • At least 8 years of experience in Clinical Data Management and a minimum of 4 years prior management experience of external vendors
  • Global clinical trials experience
  • Thorough knowledge of applicable regulatory rules and ICH guidelines
  • High proficiency of 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.