Clinical Study Start-Up Contract Lead

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.

Greater London

Hybrid

GBP 33,000 - 61,000

Full time

2 days ago
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Benefits offered by this job

Hybrid work policy
Onsite 12 days per month

Job summary

Novartis Pharmaceuticals UK Ltd. is seeking a Contracting Specialist - Clinical Study Start-Up in London. You will lead contracting activities to enable study launch and collaborate with internal and external stakeholders to negotiate contracts and manage study agreements.

The role supports country SSU strategy, ensures regulatory compliance with ICH/GCP and IRB/IEC requirements, and drives efficient processes to accelerate site activation while enabling patient recruitment.

Qualifications

  • Minimum one year of experience in clinical trials, SSU or related research environment.
  • Experience supporting clinical research, study start-up, or site-facing activities.
  • Understanding of ICH/GCP, IRB/IEC requirements and Health Authority regulations.
  • Strong communication and stakeholder management skills.
  • Demonstrated negotiation skills in financial, contractual and operational discussions.
  • Ability to manage multiple priorities and deliver high-quality outcomes on time.
  • Experience working with databases and data sources to analyze information and inform decisions.

Responsibilities

  • Support country Study Start-Up strategy with timelines, milestones and commitments.
  • Coordinate, prepare and execute contracts, confidentiality agreements and amendments.
  • Track contract status from negotiation through dispatch and return, escalating risks as needed.
  • Negotiate financial and legal terms with sites and institutions.
  • Collaborate with CRAs, CTAs, Finance and study teams to progress parallel activities.
  • Serve as primary contact for local Legal teams and Ethics Committees on contract matters.
  • Ensure contracting activities comply with ICH/GCP, IRB/IEC, HA regulations and SOPs.
  • Drive streamlined contracting processes to accelerate site activation and patient recruitment.

Skills

Clinical trials
Stakeholder management
Negotiation
Regulatory knowledge
Study Start-Up
Project management
Data analysis

Job description

Novartis Pharmaceuticals UK Ltd. is seeking a Contracting Specialist - Clinical Study Start-Up in London. You will lead contracting activities to enable study launch and collaborate with internal and external stakeholders to negotiate contracts and manage study agreements.

The role supports country SSU strategy, ensures regulatory compliance with ICH/GCP and IRB/IEC requirements, and drives efficient processes to accelerate site activation while enabling patient recruitment.

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