Clinical Data Manager
Location: South San Francisco, CA
Position type: Full-time
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immune-oncology protein therapeutics for patients with serious unmet medical needs. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development.
We currently have three protein therapeutics in clinical trials:
- FPA008 – a monoclonal antibody that inhibits the CSF-1 receptor and is being studied in multiple tumor settings and pigmented villonodular synovitis (PVNS)
- FPA144 – a monoclonal antibody targeting FGFR2b for selected gastric cancers
- FP1039 – a FGF ligand trap for mesothelioma
On the strength of our unique discovery platform and capabilities, we have entered into strategic collaborations with leading global pharmaceutical companies. We currently have three active research collaborations with Bristol-Myers Squibb, GlaxoSmithKline and UCB Pharma, S.A.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. These values are reflected in our people and our products. We value our culture of openness, collaboration and productivity. Discover more about Five Prime at www.fiveprime.com.
We are seeking a highly motivated individual to join the Five Prime Therapeutics Inc. Clinical Data Management group within the Clinical Operations function. This individual will play a key role in ensuring accurate, high quality clinical trial data for outsourced trials in a fast-paced environment. Overall responsibilities will include oversight of clinical data management activities from study startup through study closure in support of trial objectives and corporate goals. This position reports to the Director of Clinical Data Management.
Key responsibilities include:
- Provide oversight of clinical data management activities across multiple studies.
- Collaborate with cross functional Study Execution Team (SET) members and vendors to meet project deliverables, including data acquisition, quality checking and reporting in compliance with GCP, SOPs and regulatory requirements.
- Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans – identifying and mitigating risks to data quality.
- Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality.
- Participate in selection of CROs and vendors; review proposals and make award recommendations
- Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable.
- Ensure completeness, accuracy and consistency of clinical data across all assigned studies.
- Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel.
- Report query trends and data/query metrics to the study team.
- Review data transfers for consistency with available specifications, e.g. SDTM specifications, annotated CRFs.
- Lead and perform supplemental data reviews according to the data quality checks outlined in the edit check specifications document.
- Represent data management at Investigator Meetings and may present EDC and Case Report Forms to investigators.
- Implement, track and review key performance indicators on data entry, source verification, and query status; perform quality control on those metrics to ensure accuracy.
- Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells.
- Review draft TFL output prior to final database locks.
- Prioritize projects and coordinate data management activities in support of corporate goals and objectives.
- Contribute to the development of data standards in compliance with CDISC (CDASH/SDTM), and corresponding standard edit checks and data review listings.
- Participate in the review and/or development of SOPs and working practices.
- BS/BA in Life Science or related discipline
- 5+ years of clinical data management experience in the pharmaceutical/CRO industry.
- 5+ years of Electronic Data Capture (EDC) experience
- Global clinical trial and CRO management experience in oncology
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines
- Strong working knowledge of CDISC standards (CDASH and SDTM) and CDM Best Practices.
- Proficiency in MS office including Word, Excel, PowerPoint and other applications
- Experience with SAS or SQL programming techniques with clinical data management application a plus.
- Ability to manage CROs and clinical study vendors
- Effective team player and ability to collaborate with cross functional clinical study teams
- Ability to manage data management activities for outsourced clinical trials
- Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment
- Excellent written and interpersonal communication skills necessary to interface with outside vendors, consultants, and team members.
- Demonstrated strengths in planning, organizational, analytical skills, time management, problem solving, and attention to detail.
Please upload your cover letter and resume