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Clinical Study Planning Manager/Project Manager - FSP

1010 Parexel International, LLC
Carolina, NC Remote Full Time
POSTED ON 5/1/2025
AVAILABLE BEFORE 7/1/2025
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. •Lead the development of realistic study timelines, from design through final study reporting on priority programs • Maintaining accuracy of clinical study timeline information in Company data control systems (e.g., Planisware (PPM) • Tracking, documenting, and ensuring key stakeholder involvement and timely delivery of clinical study deliverables • Leading special projects as assigned • Represent CSP group in applicable forums and lead functional specific communications • Closely support Sr. Manager with Program oversight and stakeholder management, as required by the assigned program/s • Oversight of CSP staff, as required by the Sr. Manager • Develop and monitor clinical trial timelines: Ensure high-quality, realistic, cross-functional, global timelines within specified deadlines. • Conduct routine integrity checks: Regularly resolve data issues for assigned study timelines. • Manage and communicate changes: Implement changes through the CIARA process or other mechanisms. • Align funding and investment: Support operational planning by ensuring alignment of funding for clinical studies. • Collaborate and improve: Maintain strong relationships with study teams, identify bottlenecks, and contribute to continuous improvement in project management. •Lead the development of realistic study timelines, from design through final study reporting on priority programs • Maintaining accuracy of clinical study timeline information in Company data control systems (e.g., Planisware (PPM) • Tracking, documenting, and ensuring key stakeholder involvement and timely delivery of clinical study deliverables • Leading special projects as assigned • Represent CSP group in applicable forums and lead functional specific communications • Closely support Sr. Manager with Program oversight and stakeholder management, as required by the assigned program/s • Oversight of CSP staff, as required by the Sr. Manager • Develop and monitor clinical trial timelines: Ensure high-quality, realistic, cross-functional, global timelines within specified deadlines. • Conduct routine integrity checks: Regularly resolve data issues for assigned study timelines. • Manage and communicate changes: Implement changes through the CIARA process or other mechanisms. • Align funding and investment: Support operational planning by ensuring alignment of funding for clinical studies. • Collaborate and improve: Maintain strong relationships with study teams, identify bottlenecks, and contribute to continuous improvement in project management. BA/BS/BSc in the sciences or RN • 5 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical product development (clinical research or clinical operations experience obtained at a biotech, pharmaceutical or CRO company) Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience • PMP Certification #LI-LG4 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

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