Manager, Clinical Operations

San Rafael, California | Contract

Post Date: 11/27/2017 Job ID: 3609

Key Responsibilities
  • Ensure timely and quality execution of study according to the protocol, study execution plan, and GCP guidelines (including  SOPs, ICH and FDA and other Health Authorities (HAs))
  • Oversee study feasibility assessment activities (if applicable)
  •   Ensure timely development and finalization of key study plans and manuals as per the Study Team charter
  • Contribute to the development and review of critical study documents, such as study protocol, eCRF, ICF, and others
  • Identify CLO risks and mitigations and align with cross-functional Study Team on overall Risk Mitigation Plan

 

Study Planning & Management
  • Identify, resolve or, if necessary, escalate CLO issues that have a significant impact to overall study timelines, other functions, budget or quality to Study Team Lead as per Study Team charter
  • Provide CLO study activity timeline and budget inputs to overall Study Team timeline and budget
  • Lead cross-functional effort to define enrollment strategy and plan for the study
  • Participate in strategic study planning meetings (such as DMC, advisory board, steering committee)
  •   Provide study status updates to the Study Team and Study Team Lead

Vendor Mangement
  •   In collaboration with appropriate teams, oversee and approve vendor evaluation and selection
  • Oversee day-to-day management of CRO and vendors’ contracted activities as per oversight plans
  • Work with Clinical Outsourcing and Analytics (COA) group to ensure final payments to vendors at study closure

Startup:

  •   Lead site identification, qualification, selection and activation activities for the study, including activities such as site and staff training, site budgets, site ICF and coordination of site investigator contracts with Clinical Contract & Grants

  • Plan and deliver IM in collaboration with other key stakeholders

  • Enrollment and Maintenance:

  •   Ensure adherence to study enrollment strategy and plan

  • Ensure adherence to monitoring place

  •   Ensure adherence to monitoring oversight SOP

  • Ensure timely site payment

  • Partner with Patient Advocacy to manage patient travel, housing and associated management of patient costs

Closure:
  • Oversee all study closure activities (sites, reconciliation activities, filing & archiving, and e/TMF related activities)
  • Coordinate and oversee data listing reviews
  • Ensure timely delivery of clinical documents for the CSR and appendices
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