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

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 Manager to 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 knowledge of Good Clinical Practice (GCP), clinical research regulations, and standard operating procedures.
• Proficiency with project management tools, trackers, Microsoft Excel, and collaborative platforms.
• Exceptional written and verbal communication skills.
• Demonstrated ability to manage multiple studies or projects simultaneously while maintaining accuracy and meeting deadlines.

Preferred Qualifications

• Experience working within a clinical research site, site network, SMO, CRO, or sponsor organization.
• Direct experience managing multiple study activations concurrently.
• Familiarity with CTMS, eRegulatory, eSource, and EDC platforms such as CRIO, Clinical Conductor, RealTime, Florence, or comparable systems.
• Experience developing study start-up dashboards, standardized trackers, and operational performance reports.
• PMP, ACRP, SOCRA, or other relevant professional certification.
• Experience improving clinical research workflows and reducing study start-up cycle times.

Critical Success Attributes

We place significant emphasis on how this individual works, not just their technical qualifications.

Exceptionally Organized & Detail-Oriented

• Maintains meticulous trackers, documentation, and action items.
• Consistently follows through on commitments.
• Manages multiple moving pieces without losing visibility into details.
• Creates structure and clarity in complex or ambiguous environments.

Proactive & Self-Directed

• Takes initiative without waiting for direction.
• Anticipates issues and acts before they become problems.
• Brings solutions and recommendations rather than simply identifying obstacles.
• Demonstrates strong ownership of outcomes.

Accountable & Results-Driven

• Treats deadlines as commitments.
• Holds themselves and others accountable.
• Takes responsibility for moving work forward, even when deliverables depend on other teams.
• Remains focused on successful, on-time study activation.

Strong Cross-Functional Leader

• Confidently coordinates teams and stakeholders without requiring direct reporting authority.
• Communicates clearly, directly, and professionally.
• Is comfortable following up, challenging delays, and escalating when necessary.
• Builds collaborative relationships while maintaining urgency and accountability.

Thrives in a Fast-Paced Environment

• Comfortably manages competing priorities and changing timelines.
• Remains composed, focused, and organized under pressure.
• Adapts quickly while maintaining a high standard of execution.
• Demonstrates a strong sense of urgency and continuous improvement.

Key Performance Indicators / Measures of Success

Success in this role will be measured by:

• On-Time Study Activation:  Percentage of studies activated by the committed target date.
• Milestone Adherence:  Percentage of study start-up milestones completed on schedule.
• Critical Deliverable Completion:  Timely completion of required regulatory, contractual, operational, and system-readiness activities.
• Risk Identification & Resolution:  Proactive identification, escalation, and resolution of issues impacting study timelines.
• Project Visibility & Accountability:  Accuracy and completeness of study trackers, reporting, and action-item management.
• Cross-Functional Effectiveness:  Ability to drive timely decisions, remove bottlenecks, and maintain alignment across teams.
• Continuous Improvement:  Demonstrated improvements in start-up processes, coordination, and activation cycle times.

What Success Looks Like

Within the first 90 days, the successful candidate will have established strong relationships with key stakeholders, gained a clear understanding of the client's study start-up processes, and assumed ownership of assigned study timelines and deliverables.

They will demonstrate the ability to independently lead cross-functional meetings, maintain accurate project tracking, proactively identify risks, and drive accountability across departments.

Most importantly, leadership should have confidence that every assigned study is being actively managed, potential delays are identified early, and nothing is falling through the cracks.

About UniTriTeam

UniTriTeam (UTT) partners with clinical research organizations to provide specialized operational, regulatory, technology, and project management support. Our team helps clients improve efficiency, strengthen execution, and scale clinical research operations through experienced professionals and practical, results-driven solutions.

We are committed to delivering exceptional service, operational excellence, and measurable results for our clients.