Clinical Research Project Manager

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

📋 Description

• Oversee and manage the study initiation process from the initial study award or feasibility stage through to site activation and preparation for the first patient enrollment.

• Create study initiation plans, timelines, milestones, and deliverables.

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

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

• Ensure all documentation, approvals, and operational prerequisites are fulfilled prior to site activation.

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

• Facilitate cross-functional meetings, designate action-item owners, and ensure follow-through on commitments.

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

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

• Monitor deliverables, competing priorities, bottlenecks, risks, and corrective measures.

• Provide timely status updates to leadership and stakeholders.

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

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

• Maintain alignment with GCP, regulatory standards, sponsor expectations, and organizational SOPs.

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

• Proactively communicate study status, milestones, risks, and upcoming actions.

• Lead meetings with documented decisions, assigned owners, and deadlines.

• Act as a trusted partner to client leadership and ensure accountability across teams.

⛳️ Requirements

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

• A minimum of 3–5 years of experience in clinical research, specifically within clinical trial operations, site operations, or study initiation.

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

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

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

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

• Proficient in project management tools, trackers, Microsoft Excel, and collaborative platforms.

• Outstanding written and verbal communication abilities.

• Capable of managing multiple studies or projects simultaneously while ensuring accuracy and adhering to deadlines.

• Preferred: experience within 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 developing study initiation dashboards, standardized trackers, and operational performance reports.

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

• Preferred: experience in enhancing clinical research workflows and reducing study initiation cycle times.

🏝️ Benefits

• A comprehensive benefits package including health, dental, and vision insurance.

• Opportunities for professional development and continuing education.

• Flexible work hours and remote work options.

• A collaborative and supportive work environment.

• Competitive salary and performance-based bonuses.