Clinical Research Project Manager

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🔥 1 minute ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 13%

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📋 Description

• 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

• 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

• 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

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