Clinical Research Project Manager (PST/EST/CST Timezone)

About this role

Clinical Research Project Manager – Study Start-Up & Site Activation
Company: UniTriTeam (UTT)
Position: Clinical Research Project Manager – Study Start-Up
Department: Clinical Research Operations
Employment Type: Full-Time
Location: Remote / Client-Specific Requirements
Position Overview
UniTriTeam is seeking a highly organized, proactive, and results-driven Clinical Research Project Managerto support one of our clinical research clients in managing the end-to-end study start-up process.
This individual will be responsible for coordinating cross-functional teams, managing timelines, tracking critical deliverables, and ensuring clinical research studies are activated on time, with all operational, regulatory, contractual, and system requirements in place.
The ideal candidate has a strong clinical research background, thrives in a fast-paced environment, and brings exceptional attention to detail, urgency, accountability, and follow-through.
We are looking for someone who doesn't just track progress—they drive it. This person must anticipate roadblocks, take initiative, hold stakeholders accountable, and ensure that nothing falls through the cracks.
This is a highly visible, hands-on role requiring strong project management skills, clinical research knowledge, and the ability to coordinate multiple priorities and stakeholders simultaneously.
Key Responsibilities

• Study Start-Up & Site Activation

• Own and manage the study start-up process from initial study award or feasibility through site activation and readiness for first patient enrollment.

• Develop comprehensive study start-up plans, timelines, milestones, and deliverables for each assigned study.

• Coordinate start-up activities across regulatory, contracts, budgets, clinical operations, finance, recruitment, technology, and other functional teams.

• Track all required study start-up activities, including feasibility, regulatory submissions, IRB approvals, contracts, budgets, training, system readiness, and sponsor requirements.

• Ensure all study-specific documentation, approvals, and operational requirements are completed before site activation.

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

• Drive timely completion of start-up milestones while maintaining compliance and quality standards.

• Cross-Functional Project Management

• Serve as the central point of coordination across internal departments, external sponsors, CROs, vendors, and site leadership.

• Lead study start-up meetings, establish clear action items, assign owners, and ensure timely follow-through.

• Create accountability across functional teams by clearly communicating responsibilities, deadlines, and expectations.

• Proactively identify gaps in communication, handoffs, or ownership and resolve them before they impact timelines.

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

• Maintain strong working relationships with clinical research teams while driving urgency and execution.

• Ensure all stakeholders have visibility into study progress, priorities, risks, and upcoming milestones.

• Timeline, Milestone & Deliverable Management

• Build and maintain detailed project plans and study start-up trackers.

• Monitor milestone completion, deliverable status, and readiness across all active studies.

• Establish realistic timelines and proactively manage competing priorities.

• Identify bottlenecks and take immediate action to keep projects on schedule.

• Provide accurate, timely, and actionable status reporting to leadership and stakeholders.

• Maintain centralized documentation of project decisions, risks, action items, and dependencies.

• Ensure timely escalation when deliverables are at risk, including clear corrective actions and ownership.

• Operational Readiness & Quality

• Coordinate with relevant teams to ensure studies are operationally ready for activation, including staffing, training, supplies, systems, and required documentation.

• Verify readiness of applicable clinical research platforms, including CTMS, eRegulatory, eSource, EDC, and other study-specific systems.

• Ensure that required study start-up processes and documentation align with applicable GCP, regulatory requirements, sponsor expectations, and organizational SOPs.

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

• Identify opportunities to streamline workflows, improve handoffs, standardize processes, and reduce study activation timelines.

• Maintain a high standard of accuracy, completeness, and quality across all assigned projects.

• Stakeholder Communication & Reporting

• Provide concise, structured updates on study status, milestones, risks, and next steps.

• Communicate proactively rather than waiting for stakeholders to request updates.

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

• Establish clear expectations with functional leaders and team members.

• Professionally challenge missed deadlines, unclear ownership, and incomplete deliverables.

• Serve as a trusted partner to client leadership by demonstrating ownership, reliability, and sound judgment.

Required Qualifications

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

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

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

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

• Experience coordinating multiple functional departments and managing interdependent deliverables.

• Strong…