Senior Clinical Contract Specialist for Global Study Startups

1 tydzień temu

Warszawa, Mazovia, Polska Ergomed Pełny etat
About the Role

We are seeking a skilled Senior Clinical Contract Specialist to join our team in supporting global study startups. The successful candidate will be responsible for managing site contracting processes, drafting, negotiating, finalizing, and executing clinical site agreements and ancillary agreements.

Key Responsibilities
  • Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments at the country or regional level.
  • Track progress of site contracting activities during study startup or maintenance, provide clear rationale for delays, and develop contingency plans to mitigate their impact.
  • Collaborate with project management, clinical management, and clinical operations personnel to achieve project goals.
  • Act as a subject matter expert for clinical site agreement elements on assigned studies for internal and sponsor stakeholders.
  • Create and maintain document status reports and update department tools/systems and team members regularly.
  • Ensure appropriate documentation is maintained by Ergomed staff involved in the contracting process.
Requirements
  • Undergraduate or graduate degree in business, law, or life sciences or an equivalent combination of education and experience.
  • Experience in negotiating clinical site agreements and investigator grants (preferably above 2 years).
  • Good knowledge of applicable regulations, drug development, and clinical project management procedures.
  • Good understanding of specific country requirements pertaining to site contracts delivery in Poland and Germany (mandatory) and preferably other countries.
  • Ability to handle multiple tasks, meet deadlines, and deliver high-quality work in a dynamic environment.
  • Proficiency in using web applications and MS Office (Word, Excel, PowerPoint, and Outlook).
  • Attention to detail, effective oral/written communication skills, and good interpersonal skills.
Additional Information

We prioritize diversity, equity, and inclusion, creating an equal opportunities workplace and a human-centric environment where people from all cultural backgrounds, genders, and ages can contribute and grow.

To succeed, we must work together with a human-first approach because our people are our greatest strength, leading to our continued success in improving the lives of those around us.

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