Site Contract Specialist
A leading global contract research organization that specialises in comprehensive, integrated drug development, laboratory and lifecycle management services, is seeking applicants for a Site Contract Specialist position in their Paris team.
The Site Contract Specialist will manage the preparation, negotiation and finalisation of "Investigator Contracts," including contractual terms and conditions, associated investigator grant budgets, payment schedule terms and conditions with an assigned workload of sites.
- Drafting, reviewing, negotiating and finalising agreements with study sites.
- Ensuring compliance with established negotiation parameters, authority approval, contractual process and client expectations as developed by the Contract Manager and approved by sponsors.
- Ensuring compliance of budgetary guidance, templates and processes as directed by Investigator Analysts.
- Identifying and assessing legal, financial and operational risks in accordance with the company and client contractual considerations, and escalating them to an appropriate level per established processes.
- Providing recommendations and alternative resolutions to Investigator Contract negotiations through established escalation channels.
- Coordinating with internal functional departments to ensure various start-up activities are aligned with contractual activities and mutually agreed upon timelines; ensuring alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation.
- Achieving company target cycle times for site activation.
- Ensuring guidelines and processes are following for efficient escalation of out of parameter issues to the Investigator Analyst or Contract Manager role.
- Completing tracking and reporting as required.
- Drafting and negotiating contract provisions and budgetary issues within parameters.
Skills and Requirements:
- At least a BS/BA.
- At least 2 years of experience in a similar position.
- Experience working for a CRO or hospital.
- An understanding of the clinical trials agreement.
- Experience in contract negotiation with sites.
- A demonstrated ability to apply basic principles of investigator grant negotiations.
- General understanding of business and financial principles that relate to service agreements.
- Detail-oriented, with demonstrable analytical and decision based thinking skills.
- An understanding of the pharmaceutical product development process and involvement of CROs.
- Able to work independently or in a team environment.
- Good organisational and time management skills.
- Working knowledge of SOP and WPDs.
- Able to organise competing priorities logically and review outstanding contractual risk and issues.
- Able to effectively use automated systems and computerised applications, such as Microsoft Outlook, Excel, Word, etc.
- Excellent English and French oral and written skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sasha Brasero on +44 203 078 9556 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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