Clinical Research Project Manager

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🔥 10 minutes ago

🇦🇷 Argentina – 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 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

• 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

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