Associate Director, Clinical Data Management
Locations: Brisbane, California | Hayward, California | Remote, United States
The Associate Director, Clinical Data Management provides leadership and clinical data expertise to project teams and programs in a fully outsourced Clinical Data Management model. The successful candidate will have good knowledge of the end-to-end clinical research and Clinical 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 projects, vendor performance, and study budgets. This position will mentor Clinical Data Management team members and will direct activities of Arcus Clinical Data Management staff, CRO and Database Vendors. The incumbent will contribute to department initiatives and non-study projects.
- Oversee and direct Data Management service providers (e.g., EDC vendor, labs, imaging vendors, Clinical Data Management CRO/FSP) to ensure agreed upon performance on quality and timeliness of deliverables
- Lead and support 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
- Oversee the development and maintenance of data transfer agreements with external data vendors (e.g., clinical laboratories, imaging vendors, etc) and external data reconciliations.
- Responsible for ensuring data collected in the clinical database and by vendors meet the requirements of the study objective and quality standards. Manage the Arcus Clinical Data Review process, including the data query process for inconsistencies, omissions, or errors. May issue data queries in EDC.
- Represent data management on cross-functional teams, providing accurate study status updates, timeline, and proactive communication of data management deliverables and potential risks and mitigations
- Provide input to study teams on study documents (e.g., Clinical Protocols, Clinical Monitoring Plans, Statistical Analysis Plans, Safety Monitoring Plans, etc.)
- Contribute to the identification and selection of data management vendors through due diligence and proper vetting of vendor proposals.
- Develop, review, and revise SOPs, guidelines, Work Instructions, and templates
- Maintain all data management internal files, ensuring preparedness for regulatory inspections.
Knowledge, Skills, and Abilities Required
- Bachelor's Degree or higher with 10+ years' experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic Center, including previous people management experience
- Applied knowledge of ICH, FDA, and GCP regulations and guidelines
- Proven track record of on-time and high-quality Data Management deliverables
- Oncology experience required
- Highly organized, outcome oriented, self-motivated performance
- Ability to adapt to change in a fast-paced work and growth environment
- Experience with multiple EDC systems, although Medidata products preferred, through full development life cycle. (Medidata modules of interest, Rave EDC, Rave RTSM, Rave Safety Gateway, Rave Imaging, Coder, Lab Management Module; some core configuration and URL management knowledge desirable)
- Applicable knowledge of industry standards and best practices such as CDISC/CDASH
- Knowledge of and experience with MedDRA and WHO Drug data dictionaries
- Familiarity with handling lab/image data from external data sources
- Skill and knowledge in ad hoc data reporting, data review listings, metrics reporting, and standards development
- Attention to detail and the ability to work independently and oversee other CDMs within a multi-disciplinary team, as well as with external partners and vendors
- Demonstration of excellent verbal and written communication skills and positive interpersonal collaborations with colleagues.
- Successfully communicate CDM technical concepts to other functional groups for broader awareness and understanding, as well as reporting status updates within the Arcus Data Management and Biometrics Department
- Ability to train, mentor, and oversee other CDMs within a multi-disciplinary team, as well as with external partners and vendors
- May manage a variety of data management tasks for multiple clinical studies at different stages of activity in addition to functional or department initiatives
- Able to travel as needed; less than 25% travel required.
Arcus Biosciences, Inc. is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.