Clinical Project Manager

Full Time/Permanent

Responsible for executing on clinical strategies to deliver successful operational outcomes across multiple clinical trials.  Manage, plan and execute clinical studies, including creating and managing study timelines, budgets and study management plans in an outsourced model.

Primary Responsibilities

• Lead/assist the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
• Manages study operational plan and CRO activities, including project timelines and quality of deliverables and managing approved trial budget(s) throughout the life of the clinical trial(s)
• Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed
• Develop and manage study timelines (including recruitment) and may develop and manage program timelines
• Liaise with clinical staff and Investigators to ensure optimal sponsor site relationships
• Author clinical study protocols, ICFs, CSRs and other clinical documents as required
• Partner with CMC to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
• Manage study progress from planning to close out to ensure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMA, GCP and ICH guidelines
• Assists with development and implementation of policies and SOPs to be used in Clinical Operations
• Lead, plan and execute clinical investigator meetings, study meeting and vendor meetings as needed

Knowledge and Skill Requirements

• BS or MS in scientific or healthcare discipline
• 7+ years of experience in clinical research in the pharmaceutical/biotechnology industry; at least 3 as a Project Manager for clinical studies (CRO or industry)
• Experience negotiating vendor/site contracts and managing budgets
• Solid vendor management skills (CROs, laboratory and clinical supply logistics)
• Ability to interface with medical personnel at clinical sites
• Understanding of drug development from pre-IND through NDA
• Thorough understanding of FDA, ICH and GCP guidelines

Experience in Infectious Disease preferred