Here at Syneos Health we are looking for a Senior Clinical Trial Management Associate to be fully embedded with one of our Global Pharmaceutical companies. This role is home based with 2 days at client site in Buckinghamshire.

JOB SUMMARY

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

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Qualifications  

QUALIFICATION REQUIREMENTS 

    Bachelor’s Degree (or equivalent)  level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field  or equivalent combination of education and experience

• Moderate relevant clinical research experience with an understanding of clinical drug development and clinical trial operations.  Experience in a therapeutic group preferred and gained from a Pharmaceutical company or CRO.
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• Strong organizational skills.
• Ability to perform several tasks simultaneously to meet deadlines.  Self-motivation and ability to work independently.  .
• High proficiency with full MS Office Applications
• Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Ability to travel if necessary preferred (approximately 5%)