Project Manager I, RWE

Job Responsibilities

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
• 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

Business Development

• Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively.
• In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings

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

• 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%)

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Further, nothing contained herein should be construed to create an employment contract.