Description
The Manager, Clinical Data Management provides leadership and clinical data expertise to project teams in an outsourced or insourced Clinical Data Management model. The successful candidate will have advanced knowledge of the clinical research lifecycle 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. This role is responsible for managing all 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.
Responsibilities
- Lead all Data Management activities for assigned projects, including acting as the Lead Data Manager on insourced studies and acting as Oversight Data Management Lead for outsourced studies.
- Actively participate in Study Management Teams as the Data Management subject matter expert. This includes providing accurate Data Management updates and timelines during each stage of the study lifecycle, proactive communication for all Data Management topics, and complex risk assessment and mitigation planning with a firm awareness of cross functional impact.
- Lead 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.
- Ensuring data collected in the clinical and vendor databases meets the requirements for analysis, including development and maintenance of Data Transfer Agreements and vendor data transfer workflow.
- Manage 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, with at least 6 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. This includes, but is not limited to, awareness of iMedidata Cloud User and Site Administration, experience with Rave Local Lab Administration, Rave Coder, RTSM or other IRT system integrations, Rave Safety Gateway, and Rave Imaging
- Expert 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
- No travel required
This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $113,000- $155,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. 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. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.
EOE
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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