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 point of study award or feasibility through to site activation and readiness for the first patient enrollment.

• Create comprehensive study start-up plans, 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 all documentation, approvals, and operational prerequisites are fulfilled prior to site activation.

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

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

• Facilitate start-up meetings, designate action-item owners, and ensure follow-through.

• Raise awareness of risks, delays, and unresolved issues along with suggested solutions and recovery plans.

• Build and sustain project plans, study start-up trackers, milestone records, and deliverable status reports.

• Provide status updates to leadership and stakeholders, maintaining records of project decisions, risks, action items, and dependencies.

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

• Confirm 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.

• Enhance workflows, handoffs, process standardization, and study activation timelines.

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

• Promote timely study activation, milestone adherence, risk resolution, project visibility, cross-functional collaboration, 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.

• 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 grasp of the clinical trial lifecycle, encompassing feasibility, regulatory requirements, IRB submissions, contracts, budgets, and site activation.

• Experience in coordinating multiple functional departments and overseeing 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 skills.

• Ability to handle multiple studies or projects simultaneously while ensuring accuracy and meeting deadlines.

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

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

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

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

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

• Experience in refining clinical research workflows and decreasing study start-up cycle times.

• Must be highly organized and detail-oriented.

• Must be proactive, self-directed, accountable, results-oriented, and comfortable 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 matters, technology, and project management support.

• Practical, results-driven work focused on operational excellence and measurable client outcomes.