Clinical Research Project Manager

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

📋 Description

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

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

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

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

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

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

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

• Facilitate start-up meetings, delegate action item responsibilities, and ensure follow-through on tasks.

• Raise awareness of risks, delays, and unresolved issues, proposing solutions and recovery strategies.

• Construct and maintain project plans, study start-up trackers, milestone records, and deliverable statuses.

• Provide status updates to leadership and stakeholders while keeping track of project decisions, risks, action items, and dependencies.

• Coordinate operational readiness, encompassing 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 from study start-up to ongoing clinical research operations.

• Enhance workflows, handovers, process standardization, and timelines for study activation.

• Deliver structured updates, facilitate meetings, set expectations, address missed deadlines, and act as a trusted partner to client leadership.

• Promote timely study activation, adherence to milestones, risk resolution, project visibility, cross-functional efficiency, and continuous improvement.

⛳️ Requirements

• Bachelor's degree in life sciences, healthcare administration, clinical research, or a related field; equivalent relevant experience may be taken into account.

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

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

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

• Experience in coordinating several 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.

• Excellent written and verbal communication abilities.

• Capability to handle multiple studies or projects at once while ensuring accuracy and meeting deadlines.

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

• Preferred direct experience in managing multiple study activations simultaneously.

• 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.

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

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

• Must possess exceptional organizational and detail-oriented skills.

• Must be proactive, self-directed, accountable, results-oriented, and adept at coordinating cross-functional teams without direct reporting authority.

🏝️ Benefits

• Remote work arrangement.

• Full-time employment.

• Opportunity to support clinical research clients.

• Professional development through exposure to clinical research operations, regulatory, technology, and project management support.

• Practical, results-driven work that emphasizes operational excellence and measurable client outcomes.