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 project management and 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 completed 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 ensure follow-through.
- Escalate risks, delays, and unresolved issues with recommended solutions and recovery plans.
- Build and maintain project plans, start-up trackers, milestone records, and status reports.
- Coordinate operational readiness, including staffing, training, supplies, systems, and documentation.
- Verify readiness of CTMS, eRegulatory, eSource, EDC, and other study systems.
- Ensure alignment with GCP, regulatory requirements, sponsor expectations, and organizational SOPs.
- Support handoffs from study start-up to ongoing clinical research operations.
- Provide structured stakeholder updates and facilitate meetings with documented decisions, owners, and due dates.
- Improve workflows, handoffs, processes, and study activation cycle times.
- Drive on-time study activation, milestone adherence, risk resolution, project visibility, accountability, 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: 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.
Benefits:
- Remote work arrangement
- Full-time employment
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