Clinical Research Project Manager

Indeed

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

Posted 11/1/2026full-timeRemote • IndiaMid-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 project management. Proficient in coordinating cross-functional teams and ensuring compliance with 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

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Hard Skills

Clinical Trial LifecycleFeasibility AssessmentSite Activation ProcessesBudget ManagementIRB Submissions

Soft Skills

Exceptional Communication SkillsOrganizational SkillsProactive Problem SolvingDetail-OrientedCross-Functional Coordination

Tools & Technologies

CTMSERegulatoryESourceEDCMicrosoft Excel

Certifications & Qualifications

PMPACRPSOCRA

Industry Keywords

Clinical ResearchStudy Start-UpSite OperationsClinical Trial OperationsStandard Operating Procedures (SOPs)

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

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 complete 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 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 records, and deliverable status
Provide status reporting to leadership and stakeholders and maintain project decisions, risks, action items, and dependencies
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, process standardization, and study activation timelines
Provide structured updates, facilitate meetings, establish expectations, challenge missed deadlines, and serve as a trusted partner to client leadership
Drive on-time study activation, milestone adherence, 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, 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
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
PMP, ACRP, SOCRA, or other relevant professional certification preferred
Experience improving clinical research workflows and reducing study start-up cycle times
Must be exceptionally organized and detail-oriented
Must be proactive, self-directed, accountable, results-driven, and comfortable coordinating cross-functional teams without direct reporting authority

Benefits

Comp & perks

Remote work arrangement
Full-time employment
Opportunity to support clinical research clients
Professional development through exposure to clinical research operations, regulatory, technology, and project management support
Practical, results-driven work focused on operational excellence and measurable client results