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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.

Study Start Up Project Manager - FSP

Job ID 69869BR USA - Any Region - Home Based
About ExecuPharm
ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

The Start Up Project Manager is responsible for defining, developing and delivery of the Global Study Start Up Project Plan by partnering with Study Manager, Clinical Trial Application Group, Clinical Research Site Assistants, CRO Study Start Up and Site Operations Relationship Lead and others as required for Phase 3 and other supported studies.
  • Partner with Study Optimization to leverage site intelligence to inform the Start Up Project Plan.
  • Partner with the Targeted Site Investigator Network Strategy Implementation Lead to ensure accelerated start up strategies are leveraged at Targeted sites.
  • Partner with Clinical Trial Application and CRO Start Up functions to align all country and site activities to Start Up Project Plan
  • Identify risks to site activation and develop mitigation plans. This role is also accountable for resolution of Site Activation escalations for Study Teams including offering options for mitigation (both at the study and site level).
  • Leader of the Start Up Sub team and a core member of the Study Management Operations Sub team.
  • Ad-hoc member of the Core Team Meeting throughout study start up.
  • Accountable for startup of sites to be Ready to Enroll.

Qualifications

  • Extensive global clinical trial/study management experience
  • Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
  • Must have a BS/Nurse – 5 years relevant experience or MS/PhD – 3 years relevant experience
  • Prior Experience Preferred:
    • Demonstrated knowledge of site selection, site activation, site readiness interdependencies
    • Demonstrated experience leading cross functional teams
    • Demonstrated experience in Project Management activities and responsibilities
    • Previous CRO oversight experience
  • Technical expertise in the use of Site Activation tools
  • Ability to manage complex processes
  • Ability to manage in a matrix environment
  • Risk Identification & Mitigation
  • Strategic Planning, Analytical and Problem Solving Skills
  • Critical Path Analysis
  • Country level awareness and strong interpersonal skills
  • Excellent communication skills, both written and verbal. Must be fluent in English.
  • Detail oriented & possesses technical expertise (e.g.,PM tools, Gantt charts spreadsheets, metrics & data flow management)
  • Self-motivated

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.

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