Associate Director, Clinical Data Management
- 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. Our industry-leading drug discovery platform, which includes comprehensive proprietary libraries of the extracellular proteome and differentiated screening capabilities, has led to a pipeline comprising five development programs in clinical trials across multiple indications in 2019. We also have several undisclosed research programs that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process using our proprietary screens to discover new immuno-oncology targets.
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. Discover more about FivePrime at www.fiveprime.com.
We are looking for a talented Associated Director of Clinical Data Management (CDM) to join our Biometrics team. This individual will oversee the day to day CDM support of all clinical studies, including EDC build, UAT, data cleaning, data reconciliations, query generation and resolutions, database snapshots, and database locks. This position reports to the Head of Biometrics.
- Oversee all clinical data management activities or equivalent, leads strategic initiatives for the function and serves as a working data manager
- Manage and lead the design and implementation of CDM processes with vendors
- Set up and maintain standardized processes for EDC Build, Edit Check Specifications, UAT, and EDC Validation
- Ensure completeness, accuracy and consistency of clinical data and data structure
- Lead the data review cycle and field ad hoc requests for data listings from other functions
- Plan, manage and coordinate all global data management activities to ensure consistency of clinical data standards across programs
- Oversee the development of study-specific data management plans, identify potential data issues, and identify and mitigate risks to data quality
- Ensure that all data components are conducted in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the master trial file
- Oversee the preparation and maintenance of all CDM related SOPs and work instructions
- Keep abreast of literature/advancements in data collection and repository systems as well as data structures in own and related fields of drug development programs
- Works collaboratively with Biostatistics, Programming and other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
- Monitor project progress and ensure proper resource allocation for successful project deliverables against goals and timelines
- Develop and promote a work place culture that values diversity of thought and promote integrity to create an atmosphere that supports coaching and fosters accountability
- Bachelor degree or higher with 10+ years of CDM experience in the pharmaceutical industry, 8+ years with an advanced degree, oncology clinical trial experience strongly preferred
- Solid understanding of data management collection tools, experience with Medidata RAVE is preferred
- Hands-on extensive knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required.
- Full knowledge FDA/EMA regulations (particularly 21 CFR Part 11), web-based Electronic Data Capture (EDC) and clinical data management systems is also required
- Experience reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans
- Excellent writing and interpersonal communication skills to build relationship cross-functionally and collaborate effectively
- Good organizational and problem-solving skills, as well as the ability to evaluate resource needs
- Ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner.
- Ability to lead standardization processes in Data Management areas
- Ability to build a rapport and trust with others through leadership and dependability
- Ability to document deliverables following procedures with the utmost rigor 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.