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Ergomed Group

Senior Site Contracts Specialist

RemoteUnited States only
Published
Role
Operations
Experience
Senior
Employment
Full-time
Salary not disclosed
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Senior Site Contracts Specialist with 5+ years experience drafting and negotiating clinical site agreements and investigator grants. Must be US-based (remote within listed states) and have deep knowledge of Americas regulatory requirements.

What you'll do

  • Responsible for drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements and amendments at country or regional level, in accordance with project requirements and country regulations, and within projected delivery timelines.
  • Tracks in a timely manner the progress of site contracting activities during study start-up or maintenance, provides clear rationale for delays, and provides contingency plans to mitigate their impact.
  • Collaborates with the Site Contracts Lead, project management, clinical management, and clinical operations personnel to achieve project goals.
  • Responsible for creating a predictable project delivery experience for both study teams and clients alike.
  • Acts as country or regional subject matter expert for all such CSA elements on assigned studies for internal and sponsor stakeholders alike, and ensures country intelligence is up to date in country intelligence repositories.

What they require

  • Undergraduate or graduate degree in business, law, or life sciences or equivalent combination of education and experience.
  • Extensive experience in negotiating CSAs and Investigator grants (preferably above 4 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 the Americas.
  • Remarkable attention to detail.
  • Effective oral/written communication skills.
  • Ability to work proactively and effectively to meet project deadlines.
  • Good interpersonal skills.
  • Resilience and ability to manage multiple tasks, set priorities and adapt to changing work assignments.
  • Ability to exercise sound judgement and to make decisions independently.

Benefits

  • Work-life balance
  • Collaborative international team
  • Flexibility and agility
  • Remote work option (US location)

Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.

HealthcareMid-size
Salary not disclosed