Job Details

Job Description:

• The Clinical Project Manager is responsible for leading and managing human subject research studies, ensuring timely delivery, compliance, financial stewardship, and effective collaboration with internal and external stakeholders.
• This role provides strategic oversight, risk management, and operational leadership across multiple studies or programs.

• Prepare and/or review study start-up and essential documents including clinical protocols, informed consent forms, investigator brochures, monitoring plans, and related study plans.
• Serve as a Senior Clinical Project Manager to ensure study timelines and deliverables are met or exceeded.
• Schedule, lead, and document study team meetings, including preparation of meeting minutes and study documentation.
• Oversee and lead study-specific study management resources.
• Set work direction and complete tasks assigned by leadership with accountability.
• Develop and manage groups of studies for a business unit or large development program.
• Provide leadership, critical thinking, and risk mitigation during study execution.
• Lead or contribute to continuous improvement initiatives.
• Manage relationships with sites, principal investigators, CROs, and other study-related vendors.
• pply established project management standards to develop and maintain integrated project plans.
• Define, track, and report schedules, milestones, risks, critical path activities, and key deliverables.
• dapt work package deliverables based on study scale and complexity.
• Create achievable resource plans, budgets, and timelines.
• Ensure responsible stewardship of financial resources.
• Provide direction to internal and external cross-functional teams on technical, protocol, and operational aspects of studies.
• Proactively identify, track, and manage risks and issues, including escalations and mitigation plans.
• Maintain high quality and compliance standards across all study activities.
• Perform other duties as assigned.

• Strong independent judgment and analytical problem-solving ability.
• Excellent organizational, planning, and project management skills.
• bility to manage multiple priorities in complex and fast-changing environments.
• High attention to detail with emphasis on accuracy and completeness.
• Working knowledge of Good Clinical Practice and applicable regulations.
• Strong verbal and written communication skills, including scientific writing and presentations.
• bility to work effectively within cross-functional and multi-disciplinary teams.

• Three to five years of experience in human subject research or equivalent.
• Experience managing vendors and cross-functional project teams preferred.
• Experience in continuous process improvement and project management required.
• Experience with investigational drug or medical device studies preferred.
• Experience applying basic biomedical statistical methods preferred.

• Bachelor's degree required.
• dvanced degree preferred.
• PMP certification preferred.