Clinical Research Project Manager
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Job Description
Clinical research project manager driving study start-up, site activation, and operational readiness for UniTriTeam’s clinical research organization clients. Coordinating teams, timelines, risks, and deliverables.
Responsibilities:
- Own and manage the study start-up process from initial study award or feasibility through site activation and readiness for first patient enrollment
- Develop study start-up plans, timelines, milestones, and deliverables
- Coordinate regulatory, contracts, budgets, clinical operations, finance, recruitment, technology, and other functional teams
- Track feasibility, regulatory submissions, IRB approvals, contracts, budgets, training, system readiness, and sponsor requirements
- Ensure documentation, approvals, and operational requirements are complete before site activation
- Identify critical-path activities, dependencies, delays, and mitigation plans
- Lead cross-functional meetings, assign action-item owners, and drive follow-through
- Coordinate internal departments, sponsors, CROs, vendors, and site leadership
- Build and maintain project plans, trackers, milestone reports, and centralized documentation
- Monitor deliverables, competing priorities, bottlenecks, risks, and corrective actions
- Provide timely status reporting to leadership and stakeholders
- Coordinate operational readiness, including staffing, training, supplies, systems, and documentation
- Verify readiness of CTMS, eRegulatory, eSource, EDC, and other study-specific systems
- Ensure alignment with GCP, regulatory requirements, sponsor expectations, and organizational SOPs
- Support handoffs to ongoing clinical research operations and improve workflows and activation timelines
- Communicate study status, milestones, risks, and next steps proactively
- Facilitate meetings with documented decisions, owners, and due dates
- Serve as a trusted partner to client leadership and drive accountability across teams
Requirements:
- Bachelor's degree in life sciences, healthcare administration, clinical research, or a related field; equivalent relevant experience may be considered
- Minimum 3–5 years of experience in clinical research, preferably within clinical trial operations, site operations, or study start-up
- Demonstrated experience managing clinical research projects, study start-up activities, or site activation processes
- Strong understanding of the clinical trial lifecycle, including feasibility, regulatory requirements, IRB submissions, contracts, budgets, and site activation
- Experience coordinating multiple functional departments and managing interdependent deliverables
- Strong knowledge of Good Clinical Practice (GCP), clinical research regulations, and standard operating procedures
- Proficiency with project management tools, trackers, Microsoft Excel, and collaborative platforms
- Exceptional written and verbal communication skills
- Ability to manage multiple studies or projects simultaneously while maintaining accuracy and meeting deadlines
- Preferred: experience within a clinical research site, site network, SMO, CRO, or sponsor organization
- Preferred: direct experience managing multiple study activations concurrently
- Preferred: familiarity with CTMS, eRegulatory, eSource, and EDC platforms such as CRIO, Clinical Conductor, RealTime, Florence, or comparable systems
- Preferred: experience developing study start-up dashboards, standardized trackers, and operational performance reports
- Preferred: PMP, ACRP, SOCRA, or other relevant professional certification
- Preferred: experience improving clinical research workflows and reducing study start-up cycle times
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