Director, Clinical Data Management
Location: San Francisco, CA
About the position
Enliven Therapeutics is dedicated to advancing small molecule drug development programs in oncology. We are looking for a talented Director of Clinical Data Management 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 VP of Biometrics.
- Oversees all clinical data management activities or equivalent and leads strategic initiatives for the function
- Manage CROs regarding data management activities to ensure timely delivery of quality results
- Set-up and maintain standardized processes for EDC Build, Edit Check Specifications, UAT, and EDC Validation
- 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 maintain a standard documentation process for CDM activities
- Engage and energize employees through communication of goals, priorities and other business critical information as well as focus on employee development and retention activities
- 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
- BS degree or higher with 10+ years of CDM experience in the pharmaceutical industry, with oncology clinical trial experience 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
Interested applicants, please send resume to: firstname.lastname@example.org
Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.
Enliven Therapeutics does not accept resumes from recruitment agencies for this position. Recruiters, please do not send resumes to Enliven employees or to the company location. Enliven is not responsible for any fees related to unsolicited resumes.