Clinical Project Management Team Lead

Sharp Services, LLC; Bethlehem (Northampton County); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

Sharp Services, LLC seeks a Clinical Team Leader to manage and mentor Clinical Project Managers and Coordinators, guiding all clinical supplies projects across procurement, distribution, formulation/development, manufacturing, packaging and analytical services. This role will oversee timelines and quality, ensuring cGMP/SOP compliance and serving as a primary liaison with business partners.

The ideal candidate will hold a Bachelor's degree in the sciences and have 5+ years of project management

Formación

• Bachelor's 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

Responsabilidades

• 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

Conocimientos

Project management

People management

Cross-functional collaboration

Regulatory compliance

Educación

Bachelor's degree in sciences

Descripción del empleo

Sharp Services, LLC seeks a Clinical Team Leader to manage and mentor Clinical Project Managers and Coordinators, guiding all clinical supplies projects across procurement, distribution, formulation/development, manufacturing, packaging and analytical services. This role will oversee timelines and quality, ensuring cGMP/SOP compliance and serving as a primary liaison with business partners.

The ideal candidate will hold a Bachelor's degree in the sciences and have 5+ years of project management