Here at Syneos Health, we are looking for a Coordinator / Project Manager to work sponsor dedicated to a Top Pharma. You will have the chance to work in exciting Phase II/III studies.  The job location will be Client Based at Rueil Malmaison with Home Based days.

Under the direction of a Project Manager Lead supports overall project management of clinical studies by helping control the scope, schedule and cost of assigned project(s), which may range from single service studies to full scope or multiple protocol projects. Duties may include liaising with Customers, vendors and/or investigative sites to manage projects from proposal development to final deliverables to the customer.  Upon displaying proficiency, a Project Manager (PM I) may be awarded the opportunity to function at the Project Manager II (PM II) level within a large project team or on a small project which offers continued mentorship. 

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

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

Business Development

• Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively.
• May participate in Customer proposal development
• 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

Qualifications: 

• Experience of working with multidisciplinary groups (internal & external), flexibility, adaptability and ability skills to work within a matrix environment.
• Good understanding of the drug development process and knowledge of the pharmaceutical industry environment
• Good leadership skills and capability to work within a team as leader and team player
• Excellent organizational and management skills
• Intimate knowledge of regulatory requirement
• Good verbal and written communication skills (French, English)
• Good computer literacy

Benefits

• Competitive remuneration package with excellent benefits
• Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
• Opportunity to work within a successful and rewarding environment

Are you interested?

If you are interested in this role and you believe you would be the right fit, we would be more than happy to hear from you. You can apply online.

 

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