Project Manager I, RWE

🕒 July 25

🌐 Canada, United States – Remote

🇨🇦 Canada – Remote 🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Create and maintain the Trial Master File Management (TMF) Plan • Routinely review the TMF for quality, completeness, and inspection readiness • Coordinate and monitor study deliverables across internal functional departments and vendors • Assist with interim analyses, database snapshots and locks, final CSR, and study closure activities • Assist with identifying and contracting approved vendors • Manage vendors, ensuring deliverables are met, scope creep is identified, and change orders are developed • Assist with change order development and implementation • Support resource management and team member transitions by developing and implementing Transition Plans • Develop contingency plans and risk mitigation strategies to meet or exceed study milestones • Create and maintain metric reports using data from multiple sources for clients or senior management • Assist with study financial performance and obtain metrics for financial reporting • Attend financial review meetings, reconcile finances, and identify budget overruns • Review and approve invoices from sites or vendors and to the client • Represent the company to clients, communicate deliverable status, and support client satisfaction • Participate in customer proposal development • Plan, coordinate, and present internal and external meetings • Facilitate team training according to protocol and project requirements • Develop knowledge of the current therapeutic environment

🎯 Requirements

• 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 written and spoken communication, presentation, and interpersonal skills • Ability to inform, influence, convince, and persuade • Flexibility and ability to handle multiple tasks and meet deadlines while delivering high-quality work in a dynamic environment • High level of competency in English • Proficiency with MS Office applications • Ability to travel as necessary, up to 25%

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Ability to travel as necessary (up to 25%)