Manager of Clinical Data Management

Manager of Clinical Data Management

Remote or On-site Hayward/Brisbane, CA The Manager, Clinical Data Management provides leadership and clinical data expertise to project teams 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 data management components of projects and vendor performance. This position may mentor Clinical Data Management team members and may direct activities of Arcus Clinical Data Management staff, CRO and Database Vendors. The incumbent may contribute to department initiatives and non-study projects. ResponsibilitiesOversee 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 deliverablesLead 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 TestingOversee 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 mitigationsProvide input to study teams on study documents (e.g., Clinical Protocols, Clinical Monitoring Plans, Statistical Analysis Plans, Safety Monitoring Plans, etc.)May contribute to the identification and selection of data management vendors through due diligence and proper vetting of vendor proposals.May Develop, review, and revise SOPs, guidelines, Work Instructions, and templatesMaintain all data management internal files, ensuring preparedness for regulatory inspections. Knowledge, Skills, and Abilities Required Bachelor’s Degree or higher with 6+ years’ experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic CenterPractical knowledge of ICH, FDA, and GCP regulations and guidelinesProven track record of on-time and high-quality Data Management deliverablesOncology experience preferredHighly organized, outcome oriented and self-motivated performanceAbility to adapt to change in a fast-paced work and growth environmentExperience 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) General knowledge of industry standards and best practices such as CDISC/CDASHKnowledge of and experience with MedDRA and WHO Drug data dictionariesFamiliarity with handling lab/image data from external data sourcesSkill and knowledge in ad hoc data reporting, data review listings and metrics reportingAttention to detail and the ability to work independently within a multi-disciplinary team, as well as with external partners and vendorsDemonstration of excellent verbal and written communication skills and positive interactions with colleaguesSuccessfully 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 DepartmentAbility to train, mentor, and oversee other CDMs within a multi-disciplinary team, as well as with external partners and vendorsAbility to effectively manage a variety of data management tasks for multiple clinical studies at different stages of activityAble to travel as needed; less than 25% travel required.This role can be based at our Hayward or Brisbane, CA locations (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $140,000 – $150,000. For remote-based candidates, the salary range may vary based on local market data. Factors such as relevant experience, education, duration of experience, and length of industry experience will influence the actual salary offered. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package.

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