project manager in clinical research

Syneos Health is a fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes.

• Create and maintain the Trial Master File Management (TMF) Plan;
• Review the TMF to ensure 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;
• Assist with identifying and contracting approved vendors;
• Manage vendors, ensuring key deliverables are met, potential scope creep is identified, and change orders are developed;
• Assist with developing and implementing change orders;
• Support resource management and team member transitions by collaborating with Resource Managers and implementing Transition Plans;
• Develop contingency planning 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;
• Support study financial performance by obtaining metrics from internal departments and vendors for financial reporting;
• Attend financial review meetings to assist with reconciliation and budget overrun identification;
• Review and approve invoices from sites or vendors and to the client;
• Represent the company to clients, communicate deliverable statuses, and support client satisfaction;
• Participate in customer proposal development;
• Plan, coordinate, and present internal and external meetings with the Project Team;
• Facilitate team training in line with protocol and project requirements;
• Develop knowledge of the current therapeutic environment.

• Knowledge of clinical study deliverables and Trial Master File management;
• Ability to coordinate internal functional departments and vendors;
• Ability to manage vendors, deliverables, scope creep, and change orders;
• Ability to support financial reporting, reconciliation, and budget monitoring;
• Ability to develop contingency plans and risk mitigation strategies;
• Ability to facilitate therapeutic, protocol-specific, and process training;
• Ability to communicate effectively with clients, senior management, internal teams, and vendors.

• The posting is for a possible upcoming opportunity rather than a live role;
• Candidates expressing interest will be added to the talent pipeline and considered if the role becomes available;
• Career development and progression opportunities;
• Supportive line management;
• Technical and therapeutic area training;
• Peer recognition and total rewards program.