Nurse Senior Manager Clinical Operations
Company: WPA Staffing Solutions, LLC
Location: San Rafael
Posted on: March 13, 2019
Senior Manager Clinical Operations Description Industry: Pharmaceutical / Biotech Job Category: Research & Development Summary: The Sr. Manager is an experienced team lead within clinical operations, deploying communications, teamwork, and leadership skills to ensure successful clinical trial execution. The Sr. Manager holds the role of CLO Study Lead on one moderate complexity study or on multiple studies. In this role, this person leads all day-to-day Clinical Operations functional activities associated with the execution of a clinical trial. The Sr. Manager is responsible for oversight of the CLO study team, the Clinical Research Organizations (CROs), and third party vendors associated with the study. S/he is capable of overseeing and executing on all delegated tasks associated with clinical trial execution. In the case of a global, multi-country study, the Sr. Manager, may have an opportunity to oversee and develop several Regional Study Lead personnel that are leading region specific activities. Following demonstrated success in the Study Lead role, the Sr. Manager may have the opportunity to take on the Study Team Lead role for one or more low complexity studies. Responsibilities: Study Planning & Management 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 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 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 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 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 Experience: 8 years of pharmaceutical industry experience 6 years of experience in clinical research 2 or more years of line management experience Previous experience working in global environment History of successfully developing effective relationships with outside vendors and CROs Outstanding verbal communication skills which resulted in professionally communicating and guiding individual and team efforts related to Clinical Operations Demonstrated skills in negotiation, multi-tasking, organization and decision making Proficiency in databases, coding and data mining methodologies we well as Microsoft applications Ability to travel to global sites required. Prior experience working on cross-functional teams in a lead capacity Education: BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered. Compensation Full-time Benefits - Full Relocation Assistance Available - Yes Interview Travel Reimbursed - Yes Candidate Details 7+ to 10 years experience Management Experience Required - No Minimum Education - Bachelor's Degree Willingness to Travel - Occasionally
Keywords: WPA Staffing Solutions, LLC, San Rafael , Nurse Senior Manager Clinical Operations, Executive , San Rafael, California
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