Senior Portfolio Director, Clinical Operations

hace 1 mes


Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo

Overview

Syneos Health Clinical is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Estimated Salary:$130,000 - $170,000 per year

Job Description:

  • Participate in bid defense meetings and general capabilities presentations to grow TMF Operations portfolio of work.
  • Evaluate and manage budgets across the portfolio to ensure appropriate TMF Operations revenue recognition is achieved.
  • Implement processes and manage access/training for the company and/or client eTMF technologies.
  • Develop portfolio level templates for TMF Plans and/or TMF related training.
  • Present and/or ensure TMF 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 TMF objectives are met.
  • Oversee the portfolio level deliverables and KPIs.
  • Liaise with the TMF Leads Management to ensure consistency on the TMF projects oversight, including projects performance and KPIs management across portfolios.
  • Support and mentor TMF Leads on TMF project oversight for assigned portfolio.
  • Evaluate and document potential TMF risks to their assigned portfolios and develop/implement mitigation strategies. Manage escalations by following the approved communication pathway informing TMF Operations Leadership and client, as applicable.
  • Maintain effective communication with the client, Strategic Alliance Management team, TMF Operations team and project team through oral and written correspondence, portfolio level TMF Health 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 TMF.
  • Actively participate in professional organizations to keep abreast of best practices.
  • Perform oversight, hiring, training and management of TMF Operations team members such as interviewing, selection and task management, as applicable.

Required Skills and Qualifications:

  • 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.

Benefits:

We offer a range of benefits to support your well-being and career growth, including competitive compensation, comprehensive health insurance, retirement savings plan, paid time off, and opportunities for professional development and advancement.

About Syneos Health Clinical:

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



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