Clinical Research Project Manager – PST/EST/CST Timezone

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

📋 Description

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

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

• Coordinate efforts across 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 fulfilled prior to site activation.

• Identify critical-path activities, dependencies, and potential delays; implement strategies to mitigate risks.

• Ensure the 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, delegate action-item responsibilities, and ensure follow-through on commitments.

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

• Escalate risks, delays, and unresolved issues along with proposed solutions and recovery plans.

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

• Track 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.

• Assist in the transition from study start-up to ongoing clinical research operations.

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

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

• Function as a trusted partner to client leadership.

• Ensure on-time 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 also be taken into account.

• 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, specifically in feasibility, regulatory requirements, IRB submissions, contracts, budgets, and site activation.

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

• Comprehensive 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 at the same time while maintaining accuracy and meeting deadlines.

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

• Direct experience in managing multiple study activations concurrently.

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

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

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

• Experience in enhancing clinical research workflows and reducing study start-up cycle times.

• Strong organizational skills, attention to detail, proactive and self-directed approach, accountability, results-oriented mindset, cross-functional leadership, and ability to execute in a fast-paced environment.

🏝️ Benefits

• Full-time employment.

• Remote work arrangement.

• Client-specific remote requirements.

• Opportunity to collaborate with clinical research organizations.

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

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