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Senior Manager, Clinical Oversight and Optimization

JOB SUMMARY:    The Senior Manager, Clinical Oversight and Optimization is accountable for establishing and implementing, through effective collaboration with study teams, a comprehensive strategy for risk-based monitoring and vendor oversight. This position will perform required job duties with minimal guidance to ensure studies are conducted in accordance with regulations and study-specific governing documents. The Senior Manager, Clinical Oversight and Optimization is expected to provide leadership within the department and guidance on the operational governance of clinical deliverables.    ESSENTIAL FUNCTIONS: Essential functions include, but are not limited to the following: Developing  tools and strategies to empower study teams to manage and execute clinical studies in accordance with ICH GCP, protocols, study-specific plans, and company-specific SOPs Developing study-specific risk management plans in collaboration with study teams Ensuring risk management strategies and programs are implemented, maintained and enhanced to support clinical studies Reviewing data, metrics, and key performance indicators, on a regularly scheduled basis, to identify and manage potential or identified risks to data quality and patient safety Leading and engaging cross functional teams to develop internal capabilities Working in close collaboration with study teams to ensure clinical studies maintain an ongoing state of inspection readiness throughout the project life cycle Liaising with internal and external partners, to include governance reviews Reviewing  clinical documentation such as protocol, informed consent, and study-specific plans Supporting study teams to ensure Trial Master Files are set up and maintained appropriately throughout the trial, including periodic reviews for quality and completeness Participating and responding to Quality Assurance and regulatory authority inspectionaudits Participating in service provider selection process Assuming a leadership role in department or company initiatives Performing site visits including oversight and co-monitoring as needed Participating in Investigator Meetings, as needed Training and mentoring Clinical Operations Staff EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS: Bachelor's, or equivalent, degree in a scientific discipline 8+ years of clinical research experience, with at least 3 years' experience in effectively applying risk management principles to clinical study execution Demonstrated understanding of pharmaceutical regulatory requirements, both US and abroad Demonstrated knowledge of ICH and GCP Demonstrated ability to independently manage teams executing complex risk mitigation initiatives Demonstrated understanding of clinical trialprocesses, and technical expertise in driving execution Self-motivated, assertive and able to function independently or as part of a team Highly effective communication and organizational skills Strong customer service skills and attitude Able to work on multiple projects and meet deadlines Able to work in a cross functional environment Able to travel 25%-30%, domestic & international   Sangamo is an equal opportunity employer   The above reflects management's definition of essential functions for this position, but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.
Salary Range: NA
Minimum Qualification
8 - 10 years

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