Clinical Program Manager

Description

• Assists in the planning and execution of clinical projects while adhering to budget, scope and schedule requirements
• Responsible for the execution of a suite of clinical trials from protocol design to the final clinical study report
• Creates and maintains clinical program timelines for study start-up, maintenance and close-out
• Attend Clinical Development Subteam meetings and inform members of relevant clinical program updates
• Ensure study timelines are met, and study progress is tracked and reported
• Work with the clinical scientist and medical monitor to develop protocols and all documents required to initiate and conduct clinical studies (includes informed consent forms, investigator brochures, case report forms, etc.)
• Oversee performance of CROs and/and or regional CRAs to ensure compliance to the protocol and regulations, including attending site visits, co-monitoring and review of IMV reports
• Select and manage vendors required to conduct clinical studies (includes overseeing contracts, payments, and deliverables to ensure quality of service provided)
• Select study investigators and evaluate adequacy to perform research and meet study timelines
• Develop, implement, and manage project-level clinical budgets and timelines (includes communicating initial strategies and changes to project team as appropriate)
• Develop, implement, and manage monitoring plans (may include some site visits to manage site and vendor relationships and to ensure quality of data/services)
• Oversee study drug supply and ensure the project team is updated on all new developments or changes in supply needs
• Identify project risks and proactively create and implement mitigation strategies
• Collaborate effectively with cross-functional management teams and external partners
• Communicate with management to ensure adequate resources are assigned to achieve program deliverables

• Bachelor's degree in a relevant scientific discipline or equivalent.
• 8+ years of independent clinical trial management experience (including vendor management) as a CRA in the pharmaceutical industry and additionally 0-2 years of experience as a clinical project manager responsible for the implementation of multiple concurrent clinical trials.