Senior Clinical Trial Manager (Contract)
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases. We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology. Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. We value our culture of openness, collaboration and productivity. The company is in a strong financial position and has an effective executive team and Board of Directors. Discover more about FivePrime at www.fiveprime.com.
We are seeking a Sr Clinical Trial Manager (Sr. CTM) to assist the Clinical Development team in conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials.
The Sr Clinical Trial Manager (Sr. CTM) is responsible for managing the day to day operational aspects of clinical trials in compliance with the applicable GCP/ICH guidelines. This contract position will report into the Clinical Program Manager (CPM) or Associate Director/Director (AD/D) of Clinical Operations.
- Manage cross-functional Study Execution Team(s) (SET) and vendor efforts to ensure Five Prime clinical trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
- Partner with CPM/AD/D to develop and implement operational strategy for assigned clinical trials including country selection, site selection, vendor selection, study timelines and budget
- Write or contribute to preparation and finalization of project and study related documents including investigator brochure, protocols, informed consent forms, case record forms, clinical study reports, and study management plans
- Partner with SET members, vendors and sites to ensure the timely delivery of high quality clinical data; coordinate and perform routine and final database lock listings review
- Participate in selection and perform ongoing service provider management and oversight of study vendors (e.g., CRO, IxRS, Central and Specialty labs), including negotiation of scope of work, budgets, performance management, risk management and issue resolution
- Provide oversight of site management through review of CRO monitoring visit reports and Key Performance Indicators
- Proactively identify and mitigate study-specific risks. Effectively communicate study status, risks, and changes that may impact quality, timelines, and cost to internal and external stakeholders
- Manage study budget. Partner closely with CPM/AD/D to ensure accurate accruing of study costs and forecasting of study budget. Review vendor invoices against contract and work completed; identify and transparently communicate variances. Oversee reconciliation of site payments against patient visits to ensure accurate payments
- Partner with Contracts department on the development of site budget and CTA templates and negotiations with sites, until execution
- Manage clinical trial supplies required for trial execution
- Assist in the training of CROs, CRAs, vendors and site staff on study protocol and processes
- Support the management and execution of study-related meetings by developing and presenting study materials (e.g., investigators, CRA training meetings)
- Proven ability to successfully plan, implement, and manage global clinical trials
- Ability to manage cross functional clinical study teams to high performance
- Proven ability to effectively manage CROs and clinical study vendors
- Ability to negotiate with vendors and teams
- Strategic thinking skills
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines
- Highly effective verbal and written communication and presentation skills in English
Education and Experience:
- BS/BA in Life Science or related discipline
- 5+ years of experience in clinical and drug development
- lobal clinical trial and CRO management experience in oncology
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.Please call or reply with any comments.
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