Sr. Manager Clinical Trial Quality Assurance

      JOB DESCRIPTION: Sr Manager along with their leadership team, plans and manages multiple or complex/partnership cost center or Clinical Development Program(s) across all functional areas, within budget and timelines. Represents clinical development function at Advisories, interactions with Regulatory Agencies and for evaluation of business opportunities including due diligence. Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures. May have budgetary responsibility for cost center or clinical program. Ensure development of accurate study budgets, contract development and execution, payments and tracking of study expenditure. Management of personnel development, mentoring and effective delegation to direct reports to meet program goals. Effectively communicate information through the planning and execution of meetings and presentations and present recommendations to leaders. Participates in strategy development and execution for specified clinical area. Anticipate potential problems within a clinical program and create contingency plans accordingly. Elevate potential changes in regulatory or clinical environment to leadership Critical review of vendor proposals and contracts to include CRO agreements to ensure program success. Financial approval of contracts and expenses at specified level. Prioritization across teams to ensure strategic goals/milestones within Clinical Development, are met. Develops and maintains current, in-depth, relevant functional knowledge (such as scientific, technical and regulatory aspects) of projects in support of the therapeutic area on a global basis. Builds and maintains relationships with key experts and professional organizations that further the effective development of the medical device and maximize product potential. Collaborates with functional management to ensure an appropriate functional spokesperson for the project is identified to interact with relevant stakeholders, including R&D, clinical and commercial management, external experts and professional organizations and regulatory agencies. Leads and motivates functional area teams to meet key project deliverables and timelines by developing effective technical strategies, and collaborating with functional management to coordinate tactical execution by sub team members and functional organizations. a rigorous decision-making process that appropriately incorporates underlying assumptions, risks and benefits, probabilities of success, timelines, and resource requirements. Qualification Bachelor's degree or equivalent combination of education and experience. Degree in medical or scientific field desired. Advanced degree is preferred 6-8 years of direct clinical research experience with 4-6 years of clinical research management preferred, or an equivalent combination of education and work experience. IDE clinical experience is highly preferred. Management experience in other clinical operations positions desirable. Global experience preferred. Recognized leader in standard business procedures (SOPs, Global Regulations, OEC, Outsourcing) and the application of procedures to the business. Considered a Subject Matter Expert and key contributor to initiatives. Leader and key contributor to initiatives and advancement of Clinical Development as an organization. Ideal candidate will be an expert in: Good Clinical Practice ISO Standards Regulatory body inspections (i.e. FDA) CAPA Supplier Management Clinical Study Support 30907920
Salary Range: NA
Minimum Qualification
5 - 7 years

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