US-NJ, Investigator Initiated Study Coordinator
Detailed Job Description:
• Be responsible for the oversight and management of Investigator Initiated Study (IIS) Programs across the Global Ethicon Franchise, ensuring compliance with company policies and legal requirements;
• Be the point person for questions regarding the IIS program and to receive and review applications for completeness and suitability; prepare and make available application and support materials to review committee; schedule and lead review meeting; and communicate with IIS applicants
• Prepare and Present IIS applications to IIS Committee
• Assure the IIS proposals are reviewed and approved by a cross-functional committee, a contract to cover the project is executed, and study progress is demonstrated by attainment of mutually agreed upon milestones (for ongoing payments), make publically available nature and funding for a supported IIS as required by law or Company policy;
• Document meeting minutes of IIS Committees
• Follow-up on IIS Committee action items, customer follow-ups, updates and ongoing communications between customer and IIS Committee
• Help support overall IIS files, documentation and records management
• Maintain and meet IIS Metrics
• Pull IIS reports and create IIS presentations
• Facilitate communications with IIS project manager
• Coordinate with IIS Project manager to maintain updated database entry of all IIS projects
• Establish and maintain a strong partnership with the Clinical Teams and all relevant Clinical R&D partners and cross-functional partners (R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access) to manage the IIS programs, including external research (e.g., external registries)
• Summarize key product evidence from published literature and provide updates to internal stakeholders on a regular basis
• Plan for IIS study budgets and collaborate with Clinical Operations to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures;
• Verify milestones and track payments and budgets for assigned Operating Company-managed projects or IIS.
• Develop strong collaborative relationships with the study core team and others to ensure progress for IIS projects and that issues are identified and communicated to leaders.
• Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and use of clinical data/evidence for market access and reimbursement;
• Keep management informed of key developments and issues that impact clinical strategy and portfolio management;
• Support the Clinical Research team in publication planning and development and manages IIS publications tracking.
• Support the implementation of new clinical systems/processes (i.e. databases/procedures).
• Know, understand, incorporate, and comply with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• May be involved in other tasks to support external research activities as needed;
• Generally manages his/her work with limited supervision.
What are the specific skills, capabilities and years of experience needed to execute the work?
• A Bachelor’s Degree or equivalent degree in Biological Science or related discipline with at least 4 years of related scientific / technical / clinical research experience is required.
• A Life Science, Physical Science, Nursing, or Biological Science degree is preferred.
• Experience in managing IIS and post-market clinical research preferred.
• Knowledge of Good Clinical Practices (GCP) is required.
• Understanding and application of regulations and standards applied in clinical research and publication is required.
• Ability to lead study teams to deliver critical milestones is required.
• The ability to influence others along with strong written and oral communication skills is required.
• Demonstrated project management skills with the ability to handle multiple projects, and ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc.) to meet business objectives required.
• Medical device experience is preferred.
• Experience with medical writing and systematic literature review highly preferred
• Ability to build collaborative relationships with key internal and external partners and stakeholders is required.
• This position will be located in Somerville, NJ.
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