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Associate Director, Clinical Data Management (Remote)

Employer
Global Blood Therapeutics
Location
Working from Home
Start date
Jul 31, 2022

View more

Discipline
Clinical, Clinical Data, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

ASSOCIATE DIRECTOR, CLINICAL DATA MANAGEMENT (Remote)

Position Summary:

This Associate Director, Clinical Data Management role is responsible for all aspects of data management activities for the Medical Affairs studies at GBT.  The Associate Director will be responsible for late stage studies with a focus on real world evidence data, quality of life data, label extensions, and analyses of clinical data for use in reimbursement discussions as well as  data from external sources, such as devices and wearables.  This role will work closely with Medical Affairs, Biometrics, Clinical Operations, Clinical Science, and Pharmacovigilance teams to ensure data quality of GBTs trials and registries.

Essential Duties and Responsibilities:

  • Represent and provide Data Management leadership, expertise, and input to the Medical Affairs programs
  • Partner with Medical Affairs with the utilization of eCOA tools, data warehouse, and the collection of real-world data
  • Collaborate with cross functional colleagues and vendors to ensure data quality and integrity, and the achievement of Data Management deliverables and milestones
  • Be a hands-on executor as well as a strategic manager for all data management activities
  • Engage with an ownership mindset
  • Responsible for all Data Management tasks, deliverables, and timelines to support Medical Affairs programs and activities
  • Serve as a subject matter expert for Data Management operations, including but not limited to electronic data capture, data standardization, collection, and processing
  • Collaborate with internal and external partners to set goals, problem solve, and reach decisions
  • Ensure a high level of data quality and integrity by adhering to regulatory, GBT, and industry CDISC standards
  • Manage vendor partnerships by approving data management deliverables and monitoring performance
  • Lead or contribute to the development, maintenance, and compliance of Biometrics SOPs, in particular, the Data Management SOPs and Work Instructions
  • Conduct Data Management vendor and technology evaluation, selection, and qualification activities and participate in other cross functional evaluations
  • Perform Data Management budget assessments, contract negotiations, and approve invoices
  • Contribute to resource planning and manage any direct reports

Qualifications:

  • Bachelor’s degree minimum, preferably in life sciences or analytical sciences
  • At least 7-11+ years of experience in Clinical Data Management and a minimum of 6 years prior management experience of external vendors
  • Experience with global Medical Affairs studies, e.g., late stage clinical trials, registries, real world evidence data generation, quality of life data
  • Thorough knowledge of applicable regulatory rules and ICH guidelines
  • High proficiency with current Data Management technology and practices
  • Experience with CDISC standards
  • Excellent verbal and written communications skills
  • Ability to think critically, problem solve, and work independently
  • Ability to work seamlessly with team members across all functions and levels
  • 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.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

 

Company

Global Blood Therapeutics (GBT) is a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities. Founded in 2011, GBT is delivering on its goal to transform the treatment and care of sickle cell disease (SCD), a lifelong, devastating inherited blood disorder. The company has introduced Oxbryta® (voxelotor), the first FDA-approved treatment that directly inhibits sickle hemoglobin polymerization, the root cause of SCD. GBT is also advancing its pipeline program in SCD with inclacumab, a p-selectin inhibitor in development to address pain crises associated with the disease. In addition, GBT’s drug discovery teams are working on new targets to develop the next generation of treatments for SCD. To learn more, please visit www.gbt.com and follow the company on Twitter @GBT_news.

Find Us
Website
Location
181 Oyster Point Blvd
South San Francisco
California
94080
United States
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