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Manager, Clinical Operations

San Rafael, CARandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/300836

Chat with me now! - https://flashrecruit.com/jobs/295904
 

Manager, Clinical Operations

 

Job Responsibilities

  • Ensure timely and quality execution of study according to the protocol, study execution plan, and GCP guidelines (including BioMarin 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 Management

  • 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

Study Conduct

  • 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
  • Ensure adherence to study enrollment strategy and plan
  • Ensure adherence to monitoring plan
  • Ensure adherence to monitoring oversight SOP
  • Ensure timely site payments
  • Partner with Patient Advocacy to manage patient travel, housing and associated management of patient costs
  • 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
  • Oversee TMF maintenance

Education & Qualifications

  • BA/BS or higher in nursing, life or health sciences is preferred.
  • Industry or relevant experience in lieu of education is considered
  • 6 years of pharmaceutical industry experience
  • 4 years of experience in clinical research

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

 


Chat with me now! - https://flashrecruit.com/jobs/295904

 



Chat with me now! - https://flashrecruit.com/jobs/300836