Job Description

At Sharp, being resourceful is a defining value, not just a buzzword. We adapt to changing circumstances; adjusting our plans when we need to. We think through how a project might play out so we can anticipate challenges while finding clever ways to solve problems.

We’re looking for resourceful, adaptable professionals who can navigate evolving circumstances.

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