Director-Clinical Data Management

Location
South San Francisco, CA, United States
Posted
Apr 18, 2021
Ref
284921705
Discipline
Clinical, Clinical Data
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
Graphite Bio is a clinical-stage biotechnology company focused on harnessing the power of targeted DNA integration. Graphite Bio uses next-generation CRISPR based technology platforms for developing curative gene correction-based stem cell therapies for serious and life-threatening genetic diseases with inadequate existing treatment options

The Director, Clinical Data Management will be responsible for managing and overseeing all Clinical Data Management (CDM) activities required to meet corporate goals and timelines. This includes but is not limited to participation in vendor qualification and selection, development of corporate data standards, and training and oversight for all CDM services from study start-up through study close-out, final reporting and archiving. Additionally, the Director will collaborate with the Research group to establish internal CDM processes for applicable data generated within the lab.

What You WIll Do:
    • Lead clinical data management oversight of outsourced clinical trials for Graphite Bio clinical trials including project management, vendor management, coordination of internal reviews, and approval of deliverables.
    • Oversee database design and production, ensuring that CROs, vendors and internal staff meet the highest quality standards per SOPs.
    • Manages and mentors direct reports in order to achieve/meet corporate goals and milestones.
    • Oversees database design or expansion.
    • Develop and maintain SOPs and policies as required to maintain overall quality and consistency of Data Management.
    • Develop and lead strategies to improved Data management activities to be more efficient.
    • Assess and oversee platform upgrades and improvements for timely implementation.
    • Oversees data management activities to maintain consistency across trials; including Case Report Form (CRF) design, Data Management Plans, CRF annotation, edit check programs, data entry and query status tracking, and database closure.
    • Oversees the tracking of important study metrics on data entry, source verification, and query status, and presenting these metrics to a cross-functional team as required.
    • Oversees CRO/Vendor activities to ensure GCP compliance, Graphite Bio quality expectations are met and timelines are adhered to


What You Will Bring:
    • BS degree in a life science or related field and a minimum of 10 years of CDM experience in CRO, biotech or pharmaceutical industry with at least 5 years' management experience; or equivalent education and experience required;
    • Experience across all phases of clinical research; experience in gene therapy preferred
    • Experience leading the database lock of a clinical study
    • Experience managing DM teams
    • Proficient with multiple EDC platforms
    • Certified in CDASH/CDISC standards
    • Working knowledge of SAS or SQL preferred
    • Understanding the principles of clinical research, GCP (Good Clinical Practice), and GCDMP (Good Clinical Data Management Practices)
    • In-depth knowledge of clinical research and related regulatory requirements
    • Excellent communication skills (written and oral) across all organizational leve


Fit with Graphite Bio's 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 Graphite Bios' Core Values

Excitement about the vision and mission of Graphite Bio

Flexibility

Integrity

Compensation/ Benefits:

Competitive salary with equity

Free on-site gym access

Free on-site meals and coffee bar

Health benefits

Graphite Bio 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.