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Indeed

Clinical Research Project Manager

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 • ArgentinaMid-LevelSeniorWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing the study start-up process, including regulatory submissions, site activation, and project management. Proficient in coordinating cross-functional teams and ensuring compliance with Good Clinical Practice (GCP) and clinical research regulations.

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

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Clinical Trial LifecycleFeasibility AssessmentSite Activation ProcessesBudget ManagementIRB SubmissionsOperational Performance ReportingStudy Start-Up DashboardsMultiple Study CoordinationDocumentation ManagementRisk Mitigation Planning
Soft Skills
Exceptional Communication SkillsLeadershipTeam CollaborationProblem-SolvingTime Management
Tools & Technologies
CTMSERegulatoryESourceEDCMicrosoft ExcelProject Management TrackersCollaborative PlatformsCRIOClinical ConductorRealTime
Certifications & Qualifications
PMPACRPSOCRA
Industry Keywords
Clinical ResearchSite OperationsStudy Start-UpClinical Trial OperationsSponsor ExpectationsStandard Operating Procedures (SOPs)Clinical Research Organizations (CROs)Site Management Organizations (SMOs)Operational ReadinessStakeholder Communication

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 complete before site activation
  • Identify critical-path activities, dependencies, delays, and mitigation plans
  • Lead cross-functional meetings, assign action-item owners, and drive follow-through
  • Coordinate internal departments, sponsors, CROs, vendors, and site leadership
  • Build and maintain project plans, trackers, milestone reports, and centralized documentation
  • Monitor deliverables, competing priorities, bottlenecks, risks, and corrective actions
  • Provide timely status reporting to leadership and stakeholders
  • 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 to ongoing clinical research operations and improve workflows and activation timelines
  • Communicate study status, milestones, risks, and next steps proactively
  • Facilitate meetings with documented decisions, owners, and due dates
  • Serve as a trusted partner to client leadership and drive accountability across teams

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, 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
  • 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