Clinical Research Project Manager – PST/EST/CST Timezone
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Job Description
Clinical research project manager driving study start-up, site activation, and operational readiness. Supporting clinical research organizations with cross-functional coordination, timelines, risks, and compliance.
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 completed before site activation
- Identify critical-path activities, dependencies, and potential delays; implement mitigation plans
- Drive timely completion of start-up milestones while maintaining compliance and quality standards
- Serve as the central coordination point across internal departments, sponsors, CROs, vendors, and site leadership
- Lead study start-up meetings, assign action-item owners, and ensure follow-through
- Communicate responsibilities, deadlines, expectations, study progress, priorities, risks, and milestones
- Escalate risks, delays, and unresolved issues with recommended solutions and recovery plans
- Build and maintain project plans, study start-up trackers, centralized documentation, and status reports
- Monitor milestones, deliverables, readiness, competing priorities, bottlenecks, and project schedules
- 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, standardized processes, and study activation timelines
- Facilitate productive meetings with documented decisions, owners, and due dates
- Serve as a trusted partner to client leadership
- Achieve on-time study activation, milestone adherence, deliverable completion, 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, particularly 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
- Demonstrated ability to manage multiple studies or projects simultaneously while maintaining accuracy and meeting deadlines
- Experience working within a clinical research site, site network, SMO, CRO, or sponsor organization
- 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
- Experience developing study start-up dashboards, standardized trackers, and operational performance reports
- PMP, ACRP, SOCRA, or other relevant professional certification
- Experience improving clinical research workflows and reducing study start-up cycle times
- Strong organizational, detail-oriented, proactive, self-directed, accountable, results-driven, cross-functional leadership, and fast-paced execution abilities
Benefits:
- Full-time employment
- Remote work arrangement
- Client-specific remote requirements
- Opportunity to work with clinical research organizations
- Professional involvement in operational, regulatory, technology, and project management support
- Opportunities to improve efficiency, strengthen execution, and scale clinical research operations
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