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Associate Director Clinical Business Operations

Company: System One
Location: Potomac
Posted on: May 8, 2022

Job Description:

Job DescriptionJob Title: Associate Director Clinical Business OperationsLocation: Remote Type: Full Time, Salaried with benefits

Growing Biotech Company is hiring an Associate Director of Clinical Business Operations to join their team! This individual will be responsible for owning clinical systems supporting clinical operations.


  • Identify new process improvement opportunities. Leverage clinical systems data to improve transparency, efficiency, and compliance in Clinical Operations.
  • Ensure our client's study management process is well supported by clinical systems and aligned with business requirements.
  • Ensure alignment and consistency of study timelines and milestones between Clinical Operations, Global Project Management and CROs.
  • Ensure SOPs and guidance documents related to the use of clinical systems, including its integration with other business systems appropriately supports our client's study management processes.
  • Develop and maintain a 3-5-year Strategic Roadmap outlining the timing and sequencing for delivering key business capabilities (new systems) and enhancements to the existing systems to support business needs over the long term.
  • Create and implement change management strategies and plans that maximize employee adoption and usage and minimize resistance.
  • Partner with Global Project Management to ensure consistency between Veeva and MS Project
  • Work with stakeholders to support the business requirements
  • Lead the clinical systems information analytics to support our client's study metrics analysis. Engage cross functional teams to support the use of our client's Clinical Dashboards and reports.
  • Lead CTMS Data Standards to ensure streamlined data entry and workflows supporting business requirements of stakeholders.
  • Manage end user system support functions according to service level agreements, including: facilitation of user access process, triaging end user workflow/data entry issues
  • Partner with IT for the technical management and support of the CTMS.
  • Oversee and integrate the CTMS Implementation Plan into the operating model and budget, preparing for optimal operationalization of capabilities as it is delivered by the implementation team over a multi-year period. Minimum Required:
    • Bachelor's Degree
    • 10+ years of biotech, pharma and/or CRO experience, includes relevant experience in clinical systems, including CTMS (Veeva preferred) and/or clinical project management.
    • Demonstrated strong governance management in a fast paced matrixed setting, including the abilities to inform strategic decisions, to facilitate and negotiate through complex strategic decisions, to communicate with executive leadership, and lead through influence within matrix teams.
    • Solid foundation in data governance principles and experience managing large data sets.
    • Working knowledge of ICH-GCP guidelines and major Health Authority regulations
    • Proven ability to establish productive working relationships across large organizations, communicate well at all levels, and to work collaboratively to build strong partnerships.
    • Working knowledge of and experience with Medidata Rave EDC, preferably Medidata Rave
    • Experience collaborating and working with vendors, including CROs, Labs, software and consulting services.
    • Understanding of Quality management system (including computer system validation practices)
    • MS project or other GANTT charting and milestone development is a plusJoule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Keywords: System One, Potomac , Associate Director Clinical Business Operations, Executive , Potomac, Maryland

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