Contract Management Specialist / Legal Counsel F/H (IDF) CDI

Aixial : Nous recherchons un(e) Contract Management Specialist (legal counsel). Poste à pourvoir en CDI en Ile-de-France (92).

Context

The Contract Management Specialist is responsible for the timely and appropriate execution of Confidentiality Disclosure Agreements (CDAs), Clinical Study Agreements (CSAs), associated Budgets, and vendor agreements, the legal sections of the Informed Consents and issues on other legal, compliance, regulatory and policy matters (such as Insurance Policies, FMV, FCPA, etc.). In partnership with Legal they ensure that issues and points of negotiation are settled rapidly in support of our new model to minimize or eliminate negotiation and our aspirational target of first pass acceptance of these documents. The overall aim is to keep CDAs, Contracts and Budgets off the clinical study critical path for all studies (both Site Management & Monitoring and CRO conducted studies).

Responsibilities

• Serve as the point person for their country/region for Legal, Finance, Site Management & Monitoring and Study Team.
• Accountable for the timely preparation and execution of CDAs, CSAs and Budgets and related vendor agreements, either directly or via local staff where a region is supported and language requires local help. Budgets should be in line with Country Fair Market Value (FMV) and actuals should be monitored. Deviations from legally approved contract templates should be approved by Legal and should be in line with guidance provided by Legal.
• Direct negotiation of CDAs, CSAs and Budgets with investigator sites using templates, guidance and playbook from Legal where language is not a problem, or with the help of the monitor where local language necessitates.
• Deviations from legally approved contract templates should be approved by Legal and should be in line with guidance provided by Legal.
• Input into legal aspects of the Informed Consents to ensure first pass acceptance or rapid resolution of issues using the Legal playbook/guidance or Legal consult if necessary.
• Liaising with Legal where playbook doesn’t already address an issue and seeking Legal approval for deviations.
• Setting, managing and communicating priorities to local affiliate stakeholders, Legal, and Finance in alignment with study plans and priority for start-up.
• Provide input into ongoing update of the playbooks and templates with Legal.
• Tracking CDAs and CSAs in the appropriate systems and collecting relevant metrics.
• Collecting and tracking site intelligence and communicating such to appropriate stakeholders in the Study Team, Legal, Finance, etc.
• Ensuring that CDAs and CSAs are off the critical path for study start-up or study continued conduct where change orders are needed mid-study – meeting timeline commitments.

Qualifications

• Appropriate tertiary qualification, health related (Medical, Scientific, Nursing) preferred.
• Minimum three years clinical research experience including contract/budget negotiation. Proven negotiating skills, tact and diplomacy.
• Understanding of medical and legal terminology and the application of business/financial concepts used in clinical research.
• Extensive knowledge related to ICH/GCP guidelines and applicable local regulations.
• Ability to learn multiple concepts related to legal, compliance and regulatory matters in clinical research
• English and French fluent.
• Good knowledge of Tools: Ariba, OneTrust, CoMando

A propos d’Aixial

Aixial Group, CRO (Clinical Research Organization), spécialisée dans le Life Science. Nous travaillons avec les laboratoires pour apporter un support technique sur des projets cliniques des phases I à IV et post market. Depuis 2014, nous faisons partie de la famille Alten. Nous développons nos activités en France, en Belgique, Allemagne, République Tchèque, Danemark, UK, US…avec encore des perspectives de s’étendre plus à l’internationale. On continue de s’agrandir, en intégrant Larix et CMED dans nos activités.

Aixial Group, intervient en outsouring, en insourcing, pour des laboratoires pharmaceutiques, cosmétiques, du medical device, biotechnologie, nutrition,…sur des activités des opérations cliniques, des affaires réglementaires, qualité, biométrie, pharmacovigilance, HEOR…

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