Protocol Manager

A top pharmaceutical company is looking for a Clinical Protocol Manager in Wallingford, CT.

 

Responsibilities:

The Clinical Protocol Manager will be responsible for driving the successful execution of a protocol using strong project management and organizational skills including but not limited to; monitoring protocol progress, addressing and managing project obstacles, serving as a primary point of contact for the study protocols, coordinating the development of protocol level documents / plans and effectively leading a global team of individuals assigned to the protocol.

 

Core Responsibilities:

 Support protocol review committee and clinical action team Incorporate minutes into protocol and Informed Consent draft documents Organize and facilitate global and domestic clinical team meetings Provide clinical and business planning including; metric reports, milestones, capacity and accountability model, resource estimation processes, budget estimation and tracking and forecast update reports Contract negotiation with investigator sites and vendors Develop protocol risk management plan and streamline strategies for global implementation Facilitate planning sessions and study development process Partner with clinical teams to draft and implement clinical trial protocols Develop and manage Informed Consent documents and Case Report Forms Partner with clinical team on Final Study Report design and output Organize and facilitate startup/kickoff meetings Develop and implement trial monitoring plans, manage enrollment strategies with CRAs and Site Study Coordinators and facilitate cross-functional medical meetings on trial levels Review and manage milestones and mini-milestones on ongoing basis Prepare one page patient summaries, Serious Adverse Event and GCP Reports Enter and track protocol milestones and design into database

 

Requirements

 

BA/BS required, Life or Medical Sciences preferred.  Minimum four (4) years of pharmaceutical industry experience in clinical development specifically with the development of study protocols. Candidate should have proven experience in global trial management, protocol development and implementation and strong communication both verbal and written.