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Senior Manager, Legal Council - Global Site Activation

iqvia · Sofia

New
Senior 🇬🇧 English
GCP ICH Clinical site contracting

Job description

About the role

The Senior Manager, Global Site Activation, Legal Council provides expert operational support and guidance for clinical trial contracting when IQVIA Biotech is a contracting party. The role is a key point of contact for contracting matters, ensuring efficient issue resolution, consistent contract practice and alignment with internal legal and organisational requirements. It is not an in-house legal position within the legal department.

Key responsibilities

  • Provide study-specific contracting support to Project Managers, SSUMs, Site Contract Negotiators and Global Template Developers.
  • Act as the primary operational contact for complex contracting issues, escalate legal matters internally to the Legal Department as appropriate, and advise stakeholders on approved positions, templates and IQVIA contracting policies.
  • Own and maintain the Global Site Contracts Library, including country-specific templates, guidance documents and supporting materials.
  • Lead the development, validation, maintenance, translation coordination, version control and continuous improvement of contract templates, ensuring consistency with IQVIA Legal guidance.
  • Deliver training and ongoing support to Site Contracts teams on templates, processes, governance and escalation procedures.
  • Collaborate cross-functionally to drive standardisation, operational excellence and compliance, and support the evolution of contracting processes and tools.

Required profile

  • Master's degree in law and at least 5 years' experience as a qualified lawyer, preferably in a law firm or as in-house legal counsel.
  • 5 years' experience with sponsors, CROs or pharma clients, preferably in clinical site contracting.
  • Exposure to a pharmaceutical and/or CRO environment preferred.

Required skills

  • Strong negotiating and communication skills, with the ability to challenge.
  • Ability to coordinate and collaborate across and within complex projects.
  • Legal, financial and/or technical writing skills.
  • Thorough understanding of the regulated clinical trial environment and the drug development process.
  • Knowledge of GCP/ICH and applicable regulatory guidelines.

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Source : ats:workday

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Published 12 hours ago

Expires 1 month from now

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iqvia

Sofia