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Program Manager, Clinical Operations
hace 2 meses
We are seeking a highly experienced Program Manager, Clinical Operations to join our team at Syneos Health Clinical. As a key member of our operations team, you will be responsible for managing clinical programs and portfolios, ensuring timely and successful delivery of projects.
Key Responsibilities- Participate in bid defense meetings and general capabilities presentations to grow clinical operations portfolio of work.
- Evaluate and manage budgets across the portfolio to ensure appropriate revenue recognition is achieved.
- Implement processes and manage access/training for the company and/or client eTMF technologies.
- Develop portfolio level templates for clinical plans and/or related training.
- Present and/or ensure clinical related training is effectively provided to the company, client, and vendor project team members.
- Assess and collaborate on resource needs for assigned portfolios.
- Collaborate with client to establish appropriate portfolio progress and business metrics to ensure clinical objectives are met.
- Oversee the portfolio level deliverables and KPIs.
- Liaise with the Clinical Leads Management to ensure consistency on the clinical projects oversight, including projects performance and KPIs management across portfolios.
- Support and mentor Clinical Leads on clinical project oversight for assigned portfolio.
- Evaluate and document potential clinical risks to their assigned portfolios and develop/implement mitigation strategies. Manage escalations by following the approved communication pathway informing Clinical Operations Leadership and client, as applicable.
- Maintain effective communication with the client, Strategic Alliance Management team, Clinical Operations team, and project team through oral and written correspondence, portfolio level clinical KPIs reporting, and Program Review Meetings ensuring adequate documentation of each communication.
- Prepare information for internal and client meetings. May attend Trusted Process event meetings, client operations meetings, project team meetings, and training sessions.
- Prepare and participate in audits/inspections to ensure ongoing readiness of the clinical program.
- Actively participate in professional organizations to keep abreast of best practices.
- Perform oversight, hiring, training, and management of Clinical Operations team members such as interviewing, selection, and task management, as applicable.
- Minimal travel may be required (up to 25%). Performs other work-related duties as assigned.
- Undergraduate degree and experience managing a program/portfolio with direct experience managing client relationships.
- Moderate experience in a clinical and/or medical environment that includes working with regulatory records.
- Experience leading team members through direct or indirect line management preferred.
- Strong knowledge of appropriate regulations and guidelines with respect to regulatory documents and familiarity with medical terminology.
- Demonstrated leadership skills.
- Strong verbal, written, and organizational skills with a team-oriented approach.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites.
