EPM is partnered with a publicly traded clinical stage Biotech in sunny San Diego. Using a traditionally underused receptor attached to the Central Nervous System, they are unlocking the pharmaceutical development potential to treat diseases related to inflammation, metabolic disorder, and fibrosis. With a cash runway for the next few years, an upcoming Phase 3, and strong data to back all their clinical stage assets, this is one of the more exciting companies to get in with at this time.
Roles and Responsibilities
Develop comprehensive project plans outlining timelines, milestones, and resources required for successful trial execution. Ensure adherence to timelines and budget constraints throughout the project lifecycle.
Identify and evaluate clinical trial sites, negotiate contracts, and maintain relationships with investigators and site staff. Oversee site initiation, monitoring, and close-out activities to ensure compliance with Good Clinical Practice (GCP) standards.
Select, contract, and oversee third-party vendors including Contract Research Organizations (CROs), central laboratories, and clinical technology providers. Monitor vendor performance and address any issues or deviations from agreed-upon terms.
Develop and manage project budgets, track expenses, and ensure cost-effectiveness throughout the trial. Identify budget variances and implement cost-saving measures where possible.
Work closely with data management teams to ensure accurate and timely collection, management, and analysis of clinical trial data. Review study data for quality and integrity and oversee database lock and final analysis activities.
Serve as the primary point of contact for internal and external stakeholders, including study sponsors, investigators, and regulatory authorities. Provide regular updates on project progress, milestones, and issues through written reports, presentations, and meetings.
Key Qualifications
Minimum of 5-7 years of experience in clinical project management, preferably in the biotechnology or pharmaceutical industry.
Proven track record of successfully managing multiple clinical trials from start-up to close-out, including Phase I-IV trials.
Experience working with cross-functional teams and external vendors in a matrix organization.
Thorough understanding of clinical trial processes, Good Clinical Practice (GCP) guidelines, and regulatory requirements governing clinical research (e.g., FDA regulations, ICH guidelines).
Strong project management skills with the ability to develop and execute project plans, manage timelines and resources, and mitigate risks effectively.
Experience with project management tools and software (e.g., Microsoft Project, Excel, SharePoint) for planning, tracking, and reporting project progress.