Manager, Clinical Operations

Syneos Health is seeking a Manager, Clinical Operations to join their team. The successful candidate will be accountable for and provide management support and direct supervision to Clinical Operations staff in assigned areas, including Site Selection support, site contracts support, regulatory/ethics submissions, site activities, and On-Site Monitoring and/or Central Monitoring through Study Close Out.

The Manager, Clinical Operations will provide training, consultation, and oversee metric compliance and quality related to operating activities of assigned staff to ensure project deliverables are met. They will collaborate and oversee the Clinical Operations Team to ensure fulfillment of customer requirements and compliance with related regulations.

Key responsibilities include:

• Line management of Clinical Operations staff, including interviewing and selection, termination, professional development, performance appraisals, and employee counselling
• Review workload for all staff in the reporting chain and participate in managing resource availability
• Provide expert operational oversight and guidance to support prioritization of activities, review and monitor work performed, metric compliance, and development of contingency plans
• Assist in recruiting new staff, including participation in the interview process and new hire onboarding
• Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCP
• Work closely with the business unit/region to ensure staff performance on studies and correct deficiencies as identified
• Conduct sign-off and assessment visits to ensure Clinical Operations on-site performance
• Organize and chair clinical staff meetings at regular intervals
• Facilitate and support project and team/country reviews with Clinical Operations staff

The ideal candidate will have:

• A Bachelor's degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical, or biotechnology company
• At least 10 years of experience, with a preference for experience in Clinical Research, Clinical Operations, or Clinical Project Management
• At least 1 year of people management/line management experience
• Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirements
• Excellent communication, presentation, interpersonal, and change management skills
• Strong time management, technical, and organizational skills
• Knowledge of basic financial concepts as related to forecasting and budgeting
• Ability to travel up to 25%

Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards programs.