Senior Contract Negotiator (FSP) EMEA

IQVIA; Warszawa; On-site; PLN 60,000 - 75,000; Full time

Job summary

A leading global clinical research organization in Warsaw is seeking a specialist to develop contracting strategies and support clinical trial agreements. Candidates should have a Bachelor’s degree and 5 years of experience in the legal or pharmaceutical industry. Excellent communication skills and familiarity with healthcare compliance are essential for this role, which focuses on contract negotiation and amendment management.

Qualifications

• 5 years’ experience in legal/pharmaceutical industry/clinical research.
• Excellent oral and written communication skills.
• Familiarity with healthcare compliance and guidance.

Responsibilities

• Prepare and finalize clinical trial agreements.
• Analyze contractual terms and conditions.
• Support negotiations for ancillary contract documents.
• Manage the contract amendment lifecycle.

Skills

Excellent communication skills

Familiarity with healthcare compliance

Experience in legal/pharmaceutical industry

Knowledge of clinical research processes

Education

Bachelor’s degree in related field

Job description

Overview

Develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor’s requirements. Previous Investigator-Initiated or Collaborative Studies experience.

Responsibilities

• Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations. Responsible for delivery on established targets/measurements.
• Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate.
• Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
• Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
• Manage the contract amendment lifecycle.
• Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
• Assume responsibility for all aspects of legal document and metrics tracking.
• Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
• Track all aspects of legal document and metrics. Determine potential needs for contract amendments and manage amendment lifecycle.

Qualifications

• Bachelor’s degree in related field
• 5 years’ experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research.
• Excellent communication skills (both oral and written).
• Familiarity with healthcare compliance and other relevant guidance
• Familiarity with clinical research processes.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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