Manager, Clinical Data Management

Location
Hayward, California
Posted
Jun 09, 2021
Ref
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Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Summary

The Manager, Clinical Data Management provides 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 all data management components of projects, vendor performance, and study budgets.

 Responsibilities

  • Oversee 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

 Qualifications 

  • Bachelor's Degree or higher with 6+ years’ experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic Center
  • Demonstrated knowledge of ICH, FDA, and GCP regulations and guidelines
  • General knowledge of industry standards and best practices, such as CDISC/CDASH
  • Experience with multiple EDC systems through full development life cycle is required. Medidata Rave experience is preferred, including URL and Core Configuration, Architect, Rave EDC, RTSM, Rave Safety Gateway, Rave Imaging, Coder, and Lab Administration modules.
  • Knowledge of and experience with MedDRA and WHO Drug coding dictionaries
  • Familiarity with handling data from external data sources
  • Knowledge in ad hoc data reporting, data review listings and metric reporting
  • Oncology experience highly desirable
  • Proven track record of on-time and high-quality Data Management deliverables in a fast-paced working environment
  • Demonstration of excellent verbal and written communication skills and positive interpersonal collaborations with colleagues.
  • Ability to work independently and collaboratively, highly organized, attention to detail, outcome oriented, and self-motivated performance
  • Ability to effectively manage a variety of data management tasks for multiple clinical studies at different stages of activity
  • Ability to adapt to change in a growth environment
  • Able to travel to off-site meetings or training seminars 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.