Clinical Research Project Manager – PST/EST/CST Timezone

UniTriTeam

. Own and manage the study start-up process from initial study award or feasibility through site activation and readiness for first patient enrollment.

Posted 11/1/2026full-timeRemote • EgyptMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing the study start-up process, including regulatory submissions, site activation, and compliance with Good Clinical Practice (GCP). Proficient in coordinating cross-functional teams and utilizing project management tools to enhance operational efficiency and reduce study start-up cycle times.

Highest-signal resume keywords

Clinical Research Project ManagementStudy Start-Up ActivitiesRegulatory SubmissionsGood Clinical Practice (GCP)CTMS and EDC Platforms

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial LifecycleFeasibility AssessmentBudget ManagementIRB SubmissionsStudy Start-Up PlanningOperational Performance ReportingProject Management ToolsStudy Start-Up DashboardsStudy Activation ProcessesClinical Research Regulations

Soft Skills

Exceptional Communication SkillsTeam CoordinationProblem-SolvingTime ManagementAccountability

Tools & Technologies

CTMSERegulatoryESourceEDCMicrosoft ExcelCRIOClinical ConductorRealTimeFlorenceCollaborative Platforms

Industry Keywords

Clinical ResearchSite OperationsStudy ActivationClinical Trial OperationsStandard Operating Procedures (SOPs)

About the role

Key responsibilities & impact

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 study documentation, approvals, and operational requirements are complete before site activation.
Identify critical-path activities, dependencies, 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 reports, and centralized documentation.
Coordinate operational readiness, including staffing, training, supplies, systems, and required documentation.
Verify readiness of CTMS, eRegulatory, eSource, EDC, and other study-specific systems.
Ensure compliance with GCP, regulatory requirements, sponsor expectations, and organizational SOPs.
Support handoffs from study start-up to ongoing clinical research operations.
Provide structured status updates on study progress, milestones, risks, and next steps.
Facilitate meetings with documented decisions, owners, and due dates.
Drive accountability, remove bottlenecks, and improve study start-up workflows and activation cycle times.

Requirements

What you’ll need

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.
Experience improving clinical research workflows and reducing study start-up cycle times.
Ability to coordinate teams and stakeholders without direct reporting authority.
Ability to manage competing priorities and changing timelines while maintaining execution quality.

Benefits

Comp & perks

Remote work arrangement
Full-time employment
Opportunity to support clinical research clients
Professional and operational growth through work on clinical research projects
Exposure to regulatory, technology, and project management support functions
Practical, results-driven solutions and operational excellence environment