Senior Clinical Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee all elements of national and international clinical trials from the finalization of protocols to the completion of studies.

• Handle vendor selection, feasibility assessments, trial timelines, budgets, resources, and vendor relationships.

• Anticipate expenditures and pinpoint opportunities to expedite activities or reallocate funds.

• Create comprehensive study management plans in collaboration with the core project team.

• Develop and manage essential study documentation, including protocols, informed consent forms, and clinical manuals.

• Monitor external partners to ensure quality, adherence to timelines, and budget compliance.

• Guarantee that effective project plans are implemented in accordance with applicable standard operating procedures (SOPs).

• Proactively address risks and spearhead problem-solving and resolution initiatives.

• Assist in the development and upkeep of clinical SOPs and trial processes.

• Formulate project delivery strategies for requests for proposals (RFPs) and lead preparations for bid defenses.

• Manage intricate multinational and multicenter clinical research projects.

• Devise strategies for patient recruitment.

• Conduct negotiations regarding contracts and budgets with sites and vendors.

• Communicate updates on trial status, issues, and mitigation strategies to leadership and cross-functional stakeholders.

• Provide training to study team members and mentor Clinical Project Managers (CPMs).

• Operate independently with minimal supervision.

• Represent clinical operations at medical conferences through investigator engagement and presentations.

⛳️ Requirements

• A Bachelor’s degree in life sciences is required.

• Project Management Professional (PMP) certification is preferred.

• A minimum of 5 years of relevant experience in Clinical Trial Project Management is required.

• Experience with late-phase clinical trials (Phase 3 - 4, registration trials), particularly in oncology and/or radiopharmaceuticals, is preferred.

• Exceptional oral and written communication, organizational, and problem-solving skills while adhering to strict deadlines.

• A team-oriented mindset with the ability to collaborate effectively across functional teams.

• Experience managing global clinical trials is essential.

• In-depth knowledge of ICH Good Clinical Practice (GCP) and regulatory procedures.

• Capability to quickly adjust study strategies and guide teams in the appropriate direction.

• Strong analytical, organizational, planning, decision-making, negotiation, and conflict management skills.

• Proficient in the Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.) and experienced in predominantly electronic record-keeping environments.

• Proven leadership abilities and a talent for fostering the development of others.

• Experience in start-up activities, including country and site feasibility, as well as ethics and regulatory submissions across multiple regions (APAC, EMEA, NA).

• Willingness to travel up to 10% of the time.

🏝️ Benefits

• Competitive salaries.

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development.