Clinical Research Project Manager

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Take charge of and oversee the study start-up process from the initial study award or feasibility through to site activation and readiness for the enrollment of the first patient.

• Create study start-up strategies, timelines, milestones, and deliverables.

• Collaborate with regulatory, contracts, budgets, clinical operations, finance, recruitment, technology, and other functional teams.

• Monitor feasibility, regulatory submissions, IRB approvals, contracts, budgets, training, system readiness, and sponsor requirements.

• Ensure that all documentation, approvals, and operational requirements are finalized prior to site activation.

• Identify critical-path activities, dependencies, delays, and develop mitigation strategies.

• Facilitate cross-functional meetings, delegate action-item responsibilities, and ensure follow-through.

• Coordinate efforts among internal departments, sponsors, CROs, vendors, and site leadership.

• Develop and sustain project plans, trackers, milestone reports, and centralized documentation.

• Supervise deliverables, competing priorities, bottlenecks, risks, and implement corrective actions.

• Provide timely updates and status reports to leadership and stakeholders.

• Manage operational readiness, including staffing, training, supplies, systems, and documentation.

• Confirm the readiness of CTMS, eRegulatory, eSource, EDC, and other study-specific systems.

• Ensure compliance with GCP, regulatory standards, sponsor expectations, and organizational SOPs.

• Assist in the transition to ongoing clinical research operations and enhance workflows and activation timelines.

• Communicate study status, milestones, risks, and next steps in a proactive manner.

• Organize meetings with documented decisions, responsible parties, and due dates.

• Act as a reliable partner to client leadership and foster accountability across teams.

⛳️ Requirements

• Bachelor's degree in life sciences, healthcare administration, clinical research, or a related discipline; equivalent relevant experience may also be considered.

• A minimum of 3–5 years of experience in clinical research, ideally within clinical trial operations, site operations, or study start-up.

• Proven experience in managing clinical research projects, study start-up tasks, or site activation processes.

• Strong comprehension of the clinical trial lifecycle, encompassing feasibility, regulatory requisites, IRB submissions, contracts, budgets, and site activation.

• Experience in coordinating various functional departments and managing interdependent deliverables.

• Solid knowledge of Good Clinical Practice (GCP), clinical research regulations, and standard operating procedures.

• Proficiency with project management tools, trackers, Microsoft Excel, and collaborative platforms.

• Outstanding written and verbal communication abilities.

• Capacity to handle multiple studies or projects concurrently while ensuring accuracy and meeting deadlines.

• Preferred: experience in a clinical research site, site network, SMO, CRO, or sponsor organization.

• Preferred: direct experience managing multiple study activations at the same time.

• Preferred: familiarity with CTMS, eRegulatory, eSource, and EDC platforms such as CRIO, Clinical Conductor, RealTime, Florence, or similar systems.

• Preferred: experience in creating study start-up dashboards, standardized trackers, and operational performance reports.

• Preferred: PMP, ACRP, SOCRA, or other relevant professional certification.

• Preferred: experience in enhancing clinical research workflows and decreasing study start-up cycle times.

🏝️ Benefits

• Comprehensive health benefits package.

• Opportunities for career advancement and professional development.

• Flexible work arrangements and a supportive work environment.