Clinical Research Project Manager – PST/EST/CST Timezone

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 • PakistanMid-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 Written CommunicationExceptional Verbal CommunicationMulti-Project ManagementProblem-SolvingStakeholder Engagement

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 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

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: 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

Comp & perks

Remote work arrangement
Full-time employment