Clinical Research Project Manager – PST/EST/CST Timezone

Job not on LinkedIn

🔥 3 minutes ago

🇵🇰 Pakistan – 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 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

• 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

• Remote work arrangement • Full-time employment

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