Clinical Data Manager, Clinical Operations
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics. FivePrime has a differentiated discovery platform and capabilities that is fueling a growing portfolio of development candidates.
Our pipeline includes:
- Cabiralizumab (FPA008), an anti-CSF-1R antibody currently in development in a Phase 2 trial in pigmented villonodular synovitis (PVNS) and a Phase 2 trial in second-line pancreatic cancer
- FPA144, an anti-FGFR2b antibody currently in a Phase 1/3 clinical trial in FGFR2b over-expressing gastric cancer
- FPA150, an anti-B7H4 antibody will enter Phase 1 clinical development in the first half of 2018
- FPT155, a CD80 fusion protein, which is in IND-enabling studies
We have entered into strategic discovery and development collaborations with leading pharmaceutical and biotech companies, including Bristol-Myers Squibb, GSK, UCB and Zai Labs.
FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.
We are seeking a highly motivated Clinical Data Manager 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.
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.