Clinical Research Project Manager – PST/EST/CST Timezone

Indeed

. 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 • MexicoMid-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 ensure timely completion of clinical research milestones.

Highest-signal resume keywords

Clinical Research Project ManagementStudy Start-Up ActivitiesRegulatory SubmissionsGood Clinical Practice (GCP)Project Management Tools

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial LifecycleFeasibility AssessmentIRB SubmissionsBudget ManagementSite Activation ProcessesOperational Performance ReportingStudy Start-Up DashboardsStandardized TrackersWorkflow ImprovementCross-Functional Coordination

Soft Skills

Exceptional Communication SkillsDetail-OrientedProactiveResults-DrivenCross-Functional Leadership

Tools & Technologies

CTMSERegulatoryESourceEDCMicrosoft ExcelCollaborative PlatformsCRIOClinical ConductorRealTimeFlorence

Certifications & Qualifications

PMPACRPSOCRA

Industry Keywords

Clinical ResearchStudy ActivationSite OperationsClinical Trial OperationsSponsor ExpectationsStandard Operating Procedures (SOPs)Operational ReadinessStudy Start-Up ProcessMilestone AdherenceContinuous Improvement

Tech Stack

Tools & technologies

PMP

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 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

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
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

Comp & perks

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