Contracts Specialist

1 - 5 years

4 - 8 Lacs

Posted:6 days ago| Platform: Foundit logo

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Skills Required

ssu strategy master service agreements (msas) sso contracting regulatory & compliance knowledge clinical study contracting & coordination clinical trial agreements (ctas)

Work Mode

On-site

Job Type

Full Time

Job Description

Purpose:

Accountabilities

  • Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team Lead and the SSO Study Start-Up Managers to ensure SSU timelines and deliverables are met according to country commitments
  • Accountable for coordination, preparation, and execution of clinical study contracts and amendments (PI, site, institution, MSA, local vendors, etc., as applicable) for assigned projects
  • Tracks and oversees contract status including the dispatch and return of contracts
  • Negotiates financial & legal conditions, escalates issues as applicable
  • Single point of contact for local Legal and ERC (e.g., for patient reimbursement topics)
  • Develops and standardizes local contract templates (e.g., for EC submission if required by local regulation) and MSAs
  • Adheres to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
  • Implements innovative and efficient processes which are aligned with Novartis strategy

Activities & Interfaces:

  • Externally facing role with impact on Principal Investigators and Institution/Site business offices.

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Pharmaceuticals / Biotechnology

Durham

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