Senior Data Manager
Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs.
We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the “rule book” has not yet been written.
Summary of Position:
The Senior Data Manager provides leadership and clinical data expertise to project teams. The successful candidate will have a good knowledge of end-to-end clinical research and data management processes, as well as global regulatory and industry rules and guidances (i.e. ICH, GCP) to support drug or biologics development processes and global project submissions through to approval. This role is responsible for managing all data management components of project and study budgets and vendor performance. This position may mentor team members and more junior staff and may direct activities of contract Data Manager staff.
- Oversee all day-to-day data management activities, timelines and deliverables for Arcus Biosciences clinical trials from study start to database lock and delivery of data analyses.
- Lead data management study start-up activities, including development and review of eCRF requirements, EDC database specifications, eCRF completion guidelines, Data Management Plans, data validation specifications and User Acceptance Testing.
- Represent data management on cross-functional teams, providing accurate study status updates, timelines and proactive communication of data management risks.
- Contribute to the identification and selection of data management vendors through due diligence and proper vetting of vendor proposals.
- Develop and maintain data transfer agreements with external data vendors (e.g., clinical laboratories, imaging vendors). Manage interactions with outside vendors on collection, transmittal and transfer of study specific data.
- Supervise Data Management service providers (e.g., EDC vendor, labs, imaging vendors, CRO/FSP) to ensure agreed upon performance on quality and timeliness of deliverables.
- Provide input to study teams on study documents e.g. Clinical Protocols, Clinical Monitoring plans, Statistical Analysis Plans, Safety Monitoring Plans, etc.
- Responsible for ensuring data collected meets the requirements of the study objective and quality standards. Manage data query process for inconsistencies, omissions or errors.
- Maintain all data management internal files, ensuring preparedness for regulatory inspections.
- Contribute to the development, review and revision of SOPs, guidelines, Work Instructions and templates.
Knowledge, skills, and abilities required:
- Bachelor's degree or higher with 4-7 years of experience in Data Management for Pharmaceutical/ biotech/ CRO
- Practical knowledge of ICH, FDA, and GCP regulations and guidelines
- Proven track record of on-time and high-quality Data Management deliverables
- Oncology experience highly desirable
- Demonstration of excellent communication skills in writing and in interactions with colleagues
- Highly organized, outcome oriented, self-motivated performance
- Ability to adapt to change in a growth environment
- Ability to effectively manage a variety of data management tasks for multiple clinical studies at different stages of activity
- Experience with multiple EDC systems, Medidata preferred, through full development life cycle (including core configuration and URL management)
- Familiarity with handling lab/image data from external data sources
- General knowledge of industry standards and best practices such as CDISC/CDASH
- Knowledge of and experience with MedDRA and WHO Drug data dictionaries
- Skill and knowledge in ad hoc data reporting, data review listings and metrics reporting
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
- Able to travel to off-site meetings or training seminars as needed
Arcus Biosciences, Inc. is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Biotechnology, Biopharmaceutical, Pharmaceutical
Research & Development, Clinical Development