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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. 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. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.

Study Manager, Non Interventional / Observational - Research Collaboration - FSP

Job ID R0000034389

Job Summary:

We are seeking an experienced Study Manager to join our dynamic team. The ideal candidate will be responsible for managing end-to-end research collaboration studies, liaising between internal teams and external sponsors, and ensuring smooth execution of clinical trials. This role requires excellent communication skills, attention to detail, and the ability to manage multiple projects simultaneously.

Key Responsibilities:

  • Collaborate with cross-functional teams to oversee all stages of research collaboration studies
  • Serve as the primary liaison between colleagues and external researchers (sponsors)
  • Provide comprehensive management and oversight for research collaboration studies
  • Develop and implement vendor management plans, including data transfers, timeline management, and funding reconciliation
  • Contribute to protocol development and study design processes
  • Manage publication-related activities
  • Interact directly with research sites and Principal Investigators (PIs)
  • Conduct prescreening and vetting of identified sponsors, managing required documentation (e.g., CVs, PI questionnaires)
  • Assist with due diligence and contracting processes, including budget negotiations and document management
  • Coordinate with Project Managers to ensure proper connections, timely document submission, and tracking of deliverables
  • Organize and lead meetings, prepare agendas, and take minutes
  • Manage document organization using systems such as Cybergrants
  • Process invoices and manage financial aspects of studies
  • Facilitate information flow and maintain alignment among team members and sponsors

Knowledge and Experience:

  • Minimum of 2 years clinical trial management experience in a CRO or pharma setting required; management of non-interventional or observational research preferred
  • Experience managing cross functional teams
  • Knowledge of Sponsor role in research
  • Vendor management experience
  • Understanding of protocol development/study design
  • Publication management experience
  • Experience in a Site/PI facing role
  • Managing multiple projects simultaneously
  • Flexibility and willingness to learn

Education:

  • Bachelor’s of Science degree or RN – minimum of 2 years of relevant experience
  • Master’s of Science degree or Doctor of Philosophy degree – minimum of 1 year of relevant experience

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