The Clinical Project Management, Team Leader will manage & mentor Clinical Project Managers & Project Coordinators. Clinical Team Leaders are responsible for overseeing all Clinical PM activities involved with the management of clinical supplies for assigned team & accounts. This includes but is not limited to the following services: procurement, distribution, formulation/development, manufacturing, packaging and analytical services. The Clinical Team Leader will be a project resource and escalation point for the Clinical Project Managers & Project Coordinators.
Essential Duties and Responsibilities
- Direct line supervision of assigned Project Teams
- Ensure training and development for Clinical Project Managers (PM), Project Coordinators (PC), Account Managers (AM)
- Manage project coordination process and supporting framework for assigned PM/ PC team
- Oversee PMs projects and timelines for adherence
- Review incoming requests for assignments
- Promote communication among team with leading regular meetings
- Serve as the primary liaison for business partners
- Interview business partner to obtain all relevant project information
- Interpret protocols and protocol summaries and provide technical guidance to PM/PC team
- Prepare project timeline with input from key operating departments and business partner
- Ensure that Batch Records (BRs) are in compliance with cGMPs and SOPs in a timely, accurate and concise manner
- Document and ensure that background information for all projects and maintain complete record files
- Collaborate with key operating departments to meet internal dates for timely completion of requested activities
- Work with colleagues to resolve potential conflicts with projects
- Inform management and business partners of project delays and recommend appropriate solutions
- Adhere to policies, processes and SOPs to ensure compliance with cGMP, FDA and any other regulatory regulations and standards
Qualifications:
- Bachelors' Degree in the sciences and/or related experience
- 5 years in experience in Project Management, preferably in pharmaceutical clinical supplies or clinical research/supply environment/ commercial packaging
- Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines
- Experience in managing people
- Knowledge of cGMPs, FDA , DEA and OSHA Regulations and ISO guidelines, preferred
- Basic knowledge of drug product nomenclature and drug development process
