Start Up Project Manager - FSP (Dedicated to client office)

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

Organizational Relationships

• Reports to Director or Senior Director of Start-Up Project Management, or Group Lead
• Collaborates with global study managers, study operations managers, site care partners, site activation partners, investigator contract leads, feasibility specialists, clinical trial assistants, study team leads, operations planners, and process leads

Project Management

• Partner with country and site feasibility specialists to integrate current intelligence into startup strategy and site activation plans
• Coordinate with teams responsible for regulatory submissions and startup functions to align country and site activities
• Continuously assess workload across SUPMs to anticipate needs and adjust team assignments accordingly
• Oversee progress of study-specific and country-specific tasks required for site activation (e.g., vendor setup, IP supply, regulatory submissions)
• Lead project management activities to ensure timely completion of site activations
• Facilitate startup meetings to align site selection and activation activities with trial optimization plans
• Collaborate with country-level startup roles to identify opportunities to accelerate site activations while balancing priorities across concurrent studies

Plan Delivery

• Accountable for the quality and completeness of startup timeline plans at study, country, and site levels within the enterprise project management (EPM) system
• Create and manage baseline and snapshot timelines to track site activation targets
• Ensure consistent participant compensation across studies to avoid cross-study impact
• Integrate protocol amendments into activation plans and manage site green-lighting post-activation
• Responsible for site activation timelines from initial investigator package to final site activation
• Understand and manage critical path activities for each site, including:
• Timely delivery of investigator initiation packages
• Coordination with budget and contract specialists to remove delays
• Oversight of site readiness tasks (system access, training)
• Planning delivery of investigational and non-clinical supplies

Risk Mitigation

• Coordinate across study teams to assess site readiness and proactively identify and mitigate risks
• Serve as escalation point for site activation issues raised by country-level startup roles
• Resolve issues directly or triage to appropriate team members, ensuring follow-through

Process Improvement

• Identify efficiencies and improvements in site activation processes
• Share lessons learned with key stakeholders to enhance future performance

• Compliance with Parexel Standards

• Complete required training curriculum
• Submit accurate timesheets and expense reports
• Maintain updated CV
• Adhere to Parexel processes, ICH-GCP guidelines, and other applicable regulations

Skills and Competencies

• Experience in country or regional startup across at least two major therapeutic areas
• Technical proficiency in clinical study management software and reporting tools
• Ability to apply basic generative AI techniques in daily work
• Skilled in risk management methodology
• Fluent in written and spoken English

Knowledge and Experience

• Extensive global experience in clinical trial startup and study management
• Strong working knowledge of Good Clinical Practices, monitoring, and regulatory operations
• Deep understanding of clinical trial methodology
• Preferred experience includes:
• Demonstrated startup project management
• Proven project management capabilities

Education

• A scientific or technical degree is preferred
• Must have a BS/BA – 5 years relevant experience
• MS/PhD – 3 years relevant experience