THE COMPANY
89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).
THE ROLE
Reporting to the Director, Clinical Data Management and working closely with cross-functional teams on multiple clinical development programs, health authority submissions, presentations, and publications across internal and external stakeholders, the Senior Manager, Clinical Data Management will be responsible for daily data management tasks for all phases of clinical trials including oversight of CRO data management activities and support other functional areas such as programming and biostatistics. The Senior Manager, Clinical Data Management will ensure the accuracy, consistency, completeness, and high quality of the clinical database and filed documentation.
SPECIAL ADVISORY
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THE RESPONSIBILITIES
- Oversee 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
- Oversee database design, migration or expansion, including UAT and documentation
- Proactively identify risks and execute risk mitigation strategies; Maintain timely communication with both upper management and cross-functional teams
- Oversee 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
- Perform reviews of clinical trial data to ensure all captured data follows the rules outlined by the protocol and Data Management Plan
- Support cross-functional activities related to biometrics, regulatory submissions and clinical program development as needed
THE QUALIFICATIONS
- BS degree in a life science or related field preferred
- Minimum of 5+ years of CDM experience in biotech or pharmaceutical industry; or equivalent education and experience required
- Ability to manage multiple programs, and multiple studies within a program
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Experience supporting Phase 3 studies, BLA submission and FDA/MHRA audits
- Proficient in CDMS (ex: Medidata, Clintrak), Microsoft Office Suite (ex: Word, Excel, PowerPoint)
- Understand the principles of clinical research (ex: ICH GCP, CDISC and GCDMP)
SALARY & LEVEL
89bio considers a range of factors when determining the salary and level. These considerations mean actual salary and level may vary. The salary range for this position is $149,000 – $191,000 and will be commensurate with experience.
THE PERKS
- Competitive health insurance coverage
- Generous PTO allowance
- 401k match
- Employee Stock Purchase Plan (ESPP)
- Commuter Benefits
- Women's forum / mentoring
- Office based in the heart of San Francisco, near plenty of shops and restaurants
- Fun opportunities to engage with co-workers in-person and remotely
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Proof of Covid vaccination is a condition of employment.
Notice to Recruiters: To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.
