Temporary Clinical Data Specialist or Clinical Trial Specialist
- 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
- Bemarituzumab (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 individual to join the Five Prime Therapeutics Inc. Clinical Operations department. This individual will be appointed to a specialized project and will play a key role in ensuring the quality of the Electronic Data Capture (EDC) query management process and assessing data quality trends to report back to Study Execution Team (SET). This position reports to the Director of Clinical Data Management, or a Clinical Program Manager in Clinical Operations.
Key responsibilities include:
- Perform quality control (QC) of Sponsor and/or Clinical Research Organization (CRO)-issued data queries to ensure the accuracy of site responses in EDC.
- Perform ongoing assessments and report data quality trends and data/query metrics to the study team.
- Support Clinical Operations and Clinical Data Management study team members relative to ongoing data review including running various data cleaning reports.
BS/BA in Life Science or related discipline
Minimum of 3 years of Clinical Data Management or Clinical Operations experience in the pharmaceutical/CRO industry
Minimum of 3 years of Electronic Data Capture (EDC) experience
Oncology experience and knowledge of RECIST 1.1 highly preferred
Strong working knowledge of FDA & ICH/GCP regulations and guidelines
Effective team player and ability to collaborate with cross functional clinical study teams
Excellent written and interpersonal communication skills
Strong 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.