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.