Clinical Research Project Manager
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Job Description
Clinical research project manager driving study start-up, site activation, and cross-functional delivery. Supporting UniTriTeam's clinical research organization clients with compliant, on-time execution.
Responsibilities:
- Own and manage the study start-up process from 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, potential delays, and mitigation plans
- Serve as the central coordination point for internal departments, sponsors, CROs, vendors, and site leadership
- Lead start-up meetings, assign action-item owners, and drive follow-through
- Escalate risks, delays, and unresolved issues with recommended solutions and recovery plans
- Build and maintain project plans, study start-up trackers, milestone records, and deliverable status
- Provide status reporting to leadership and stakeholders and maintain project decisions, risks, action items, and dependencies
- 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 from study start-up to ongoing clinical research operations
- Improve workflows, handoffs, process standardization, and study activation timelines
- Provide structured updates, facilitate meetings, establish expectations, challenge missed deadlines, and serve as a trusted partner to client leadership
- Drive on-time study activation, milestone adherence, risk resolution, project visibility, cross-functional effectiveness, and continuous improvement
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
- 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
- PMP, ACRP, SOCRA, or other relevant professional certification preferred
- Experience improving clinical research workflows and reducing study start-up cycle times
- Must be exceptionally organized and detail-oriented
- Must be proactive, self-directed, accountable, results-driven, and comfortable coordinating cross-functional teams without direct reporting authority
Benefits:
- Remote work arrangement
- Full-time employment
- Opportunity to support clinical research clients
- Professional development through exposure to clinical research operations, regulatory, technology, and project management support
- Practical, results-driven work focused on operational excellence and measurable client results
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