Clinical Research Project Manager – PST/EST/CST Timezone

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

📋 Description

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

• Create comprehensive study start-up plans, defining timelines, milestones, and deliverables.

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

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

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

• Identify critical-path activities and dependencies, recognizing potential delays and implementing mitigation strategies.

• Ensure timely completion of start-up milestones while upholding compliance and quality standards.

• Act as the primary coordination point among internal departments, sponsors, CROs, vendors, and site leadership.

• Lead study start-up meetings, assigning action item ownership and ensuring follow-through on tasks.

• Communicate responsibilities, deadlines, expectations, study progress, priorities, risks, and milestones effectively.

• Escalate risks, delays, and unresolved issues, providing recommended solutions and recovery plans.

• Develop and maintain project plans, study start-up trackers, centralized documentation, and status reports.

• Oversee milestones, deliverables, readiness, competing priorities, bottlenecks, and project schedules.

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

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

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

• Support transitions from study start-up to ongoing clinical research operations.

• Enhance workflows, handoffs, standardized processes, and study activation timelines.

• Facilitate effective meetings with documented decisions, owners, and due dates.

• Act as a trusted partner to client leadership.

• Achieve timely study activation, adherence to milestones, completion of deliverables, resolution of risks, 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.

• 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 activities, or site activation processes.

• Strong comprehension of the clinical trial lifecycle, particularly in feasibility, regulatory requirements, IRB submissions, contracts, budgets, and site activation.

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

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

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

• Outstanding written and verbal communication skills.

• Proven ability to manage multiple studies or projects simultaneously, maintaining accuracy and meeting deadlines.

• Experience gained within a clinical research site, site network, SMO, CRO, or sponsor organization.

• Direct experience in concurrently managing multiple study activations.

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

• Experience developing study start-up dashboards, standardized trackers, and operational performance reports.

• PMP, ACRP, SOCRA, or other relevant professional certification is a plus.

• Experience in improving clinical research workflows and shortening study start-up cycle times.

• Strong organizational, detail-oriented, proactive, self-directed, accountable, results-driven, cross-functional leadership, and fast-paced execution capabilities.

🏝️ Benefits

• Full-time employment.

• Remote work arrangement.

• Client-specific remote requirements.

• Opportunity to collaborate with clinical research organizations.

• Professional involvement in operational, regulatory, technology, and project management support.

• Opportunities to enhance efficiency, strengthen execution, and scale clinical research operations.