Senior Clinical Data Manager

February 25

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

⏳ Contract/Temporary

🟠 Senior

📊 Data Scientist

🦅 H1B Visa Sponsor

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Arcus Biosciences

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Arcus Biosciences is a rapidly growing, clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines that may have the potential to help people with cancer live longer.

Protein Therapeutics • Immuno-oncology • Medicinal Chemistry • Large Molecule Drug Discovery

501 - 1000 employees

📋 Description

• The Senior Clinical Data Manager provides clinical data expertise to project teams in an outsourced and/or insourced Clinical Data Management model. • The successful candidate will have advanced knowledge of end-to-end clinical research lifecycle and Clinical Data Management processes. • This role is responsible for managing Data Management components of projects, including vendor performance for outsourced projects. • This position may mentor Clinical Data Management team members and may direct activities of Arcus Clinical Data Management vendors. • The incumbent may contribute to department initiatives and non-study projects. • Support all Data Management activities for assigned projects, including outsourced and/or insourced models. • May act as the Lead Data Manager or Support Data Manager on insourced studies and act as Oversight Data Management Lead or support for outsourced studies. • Actively participate on cross functional teams as the Data Management subject matter expert. • Lead and/or support Data Management start-up activities, such as development and review of protocols, EDC database development documentation and activities, eCRF Completion Guidelines, Data Management Plans, and cross functional collaboration. • Ensure data collected in the clinical and vendor databases meets the requirements for analysis. • Participate in all aspects of data cleaning and review, including routine data cleaning, third party data reconciliation, query management, metrics reporting, and cross functional data health communication and documentation. • Review and contribute to cross functional study documents, such as Protocols, Clinical Monitoring Plans, Statistical Analysis Plans, Safety Monitoring Plans, and presentation slide decks. • Maintain all Data Management documentation, ensuring preparedness for regulatory inspections. • Collaborate with internal and external stake holders for data transfers and data analytics activities. • May develop, review, and revise SOPs, Work Instructions, and Templates.

🎯 Requirements

• Bachelor's Degree , or commensurate experience • at least 4 years’ experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic Center • Oncology preferred • Excellent verbal and written communication skills. • Ability to communicate Data Management and EDC technical concepts to cross functional groups for awareness and understanding. • Highly organized, collaborative, detail-oriented, outcome-oriented, and self-motivated. • Ability to prioritize, adapt, and evolve tasks and processes in a fast-paced environment. • Effectively manage a variety of Data Management tasks for multiple clinical studies at different stages of activity. • Robust experience with EDC systems. • Medidata skills strongly preferred. • Advanced awareness of data collection and data cleaning best practices. • Firm understanding and proven success managing vendors and data transfer workflows. • Practical knowledge of ICH, FDA, and GCP regulations and guidelines, and general knowledge of industry data collection and reporting standards and best practices, such as SDTM and CDISC/CDASH.