Manager, Clinical Operations FSP
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Job Description
Manager overseeing clinical operations in a biopharmaceutical solutions organization. Collaborating with multifunctional teams and ensuring service delivery and compliance with KPIs.
Responsibilities:
- responsible for direct interaction with the customer points of contact (s) (PoC) on service delivery for their team members (direct reports)
- develops and fosters strong, collaborative relationships with customers at a local level, promoting high levels of trust and satisfaction
- manages performance and daily activities of multifunctional team members to excel in service delivery and compliance with agreed-upon KPIs; develops and executes mitigation and remediation plans for non-compliance as needed
- participates in managing the resource availability for their team members to ensure they are suitably resourced and resource needs are identified in a timely fashion; resolves potential resourcing conflicts to facilitate mutually beneficial resolutions
- solicits feedback from customer PoC (s) for continuous improvement of service delivery and to strengthen customer relationships
- proactively communicates and manages customer issues through assigned escalation channels
- ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCPs
- may conduct oversight visits as required for Clinical Research Associates
- responsible for all system updates, and compliance to systems and relevant procedure and practices applicable to the customer and Syneos Health processes
- drives revenue by attracting, selecting and retaining the right talent
- continues to assess and places talent on projects leveraging core competencies, margin impact and alignment to customer requirements
- supports team members’ professional development through coaching, providing opportunities to increase knowledge and skill levels, and by delegating tasks commensurate with skill level
Requirements:
- Bachelor’s degree in life sciences, nursing degree, or equivalent related experience
- extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience
- extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirement
- excellent communication, presentation, interpersonal skills; both written and spoken, with an ability to inform, influence, convince, and persuade
- strong time management, technical and organizational skills
- ability to work independently and within a team environment
- creative problem solver who is self-motivated, flexible, open to change, collaborative, and possesses a customer-centric mindset
- knowledge of basic financial concepts as related to forecasting and budgeting
- must demonstrate good computer skills and be able to embrace new technologies
- ability to travel as necessary (up to 25%)
Benefits:
- career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
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