Site Contracts Specialist

1 dzień temu

Warszawa, Mazovia, Polska Ergomed Pełny etat
Job Title: Senior Site Contracts Specialist

We are seeking a highly skilled Senior Site Contracts Specialist to join our Global Study Start Up Group. As a key member of our team, you will be responsible for managing the site contracting process locally or across a region in support of assigned projects.

Key Responsibilities:
  • Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments at country or regional level.
  • Track progress of site contracting activities during study start up or maintenance and provide clear rationale for delays, as well as a contingency plan to mitigate their impact.
  • Collaborate with site contracts lead, project management, clinical management, and clinical operations personnel to achieve project goals.
  • Act as country or regional subject matter expert for all CSA elements on assigned studies for internal and sponsor stakeholders alike.
  • Create and maintain document status reports and update department tools/systems and team members on a regular basis.
  • Ensure appropriate documentation is maintained by Ergomed staff assigned to the contracting process.
  • Contribute to site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms within corporate and industry standards during negotiation with sites.
  • Participate in regular study calls to facilitate communication as needed.
  • Establish strong working relationships and collaboration with Sponsor to ensure smooth negotiations and repeat business with Ergomed.
  • Collaborate with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
  • Be accountable for site contracts delivery of assigned projects/countries.
Requirements:
  • Undergraduate or graduate degree in business, law, or life sciences or equivalent combination of education and experience.
  • Experience in negotiating CSAs 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 to meet deadlines, delivering high-quality work in a dynamic environment.
  • Ability to exercise sound judgment and make decisions independently.
  • 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.
  • Excellent English both speaking and writing.
  • Fluent in Polish and German language.
What We Offer:
  • Training and career development opportunities internally.
  • Strong emphasis on personal and professional growth.
  • Friendly, supportive working environment.
  • Opportunity to work with colleagues based all over the world, with English as the company language.

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