Société : Pharmaceutical Research Associates, Inc Lieu : Paris 92210
Overview
The Seniorcontractanalyst plays an important role in driving the costings and contracts, being responsible for negotiation and budgeting in clinical trials and for developing and managing contracts and annexes with investigators and institutions or external vendors, ensuring ethical, fair, and compliant practices.
The Seniorcontractanalyst has regular communication with investigators and institutions as well as other key external and internal stakeholders.
Responsibilities
Adapt global templates of agreements to local use in accordance with local requirements and SOPs.
Develop and negotiate clinical site budgets based on Fair Market Value.
Negotiate agreement language and budget with clinical study sites.
Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.
For each agreement, maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources.
Ensure final contract documents are consistent with agreements reached at negotiations.
Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines.
Support internal and external audit activities.
Ensure compliance with sponsor’s Code of Conduct and company policies and procedures relating to people, finance, technology, and security.
Ensure that all contracts are included in the TMF.
Qualifications
Bachelor degree in related discipline, preferably in life science, law, finance or equivalent qualification.
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
Good knowledge of relevant local French regulations.
Basic understanding of the drug development process.
Good understanding of Clinical Study Management including monitoring, study drug handling, and data management.
Excellent attention to detail.
Good written and verbal communication skills.
Good collaboration and interpersonal skills.
Good negotiation skills.
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