Project Administration -Creates and maintains the Trial Master File Management (TMF) Plan. Routinely reviews the TMF to ensure quality, completeness and inspection readiness -Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors. -Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closure -Assists with identification of and contracting with approved vendors, as necessary -Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary -Assists with development and implementation of change orders -Assists with resource management and team member transition by collaborating with appropriate Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently Financials/Reporting -Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones. -Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management -Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting -Attends financial review meetings to assist with reconciliation and identification of budget overrun -Reviews and approves invoices from sites or vendors and to the client Knowledge/Training -Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training -Develops knowledge of current therapeutic environment
Qualifications - External What we’re looking for -Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred -Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred. CRO and relevant therapeutic experience preferred -Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements -Strong organizational skills -Strong ability to manage time and work independently -Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade -Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment -High level of competency in English language -Proficiency with MS Office Applications -Ability to travel as necessary (up to 25%)
