Theradex Oncology has designed and performed more than 350 early-phase oncology trials to date. As a full service CRO, Theradex Oncology knows how to assist its clients in developing successful strategies and execute studies in cancer treatment. Our mission is to ensure that new opportunities in drug development have the very best chance to be of benefit to mankind, with a vision to make cancer a livable disease. With 42 years of experience focused entirely on oncology, we are passionate specialists. We understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Our head office is based in Princeton, NJ, USA, while our European operations are managed from our London office.

We are looking for native Italian speaking, Freelance, Clinical Site Contract Specialist based in Italy on a 6 months (possibility to extend) contract for 0.5 FTE.

Key Responsibilities:

The primary responsibilities of this position include, but are not limited to, the following:

• Directly negotiating and finalizing Clinical Trial Agreements and Budgets for Industry-Sponsored Clinical Trials in Clinical Studies from phase I till Phase IV in Italy and UK according to instructions, timelines and milestones agreed with Senior Contract Manager and Study Team.
• Become Subject Matter Expert in the negotiation with the Spanish sites for all clinical trial studies in the Company.
• Liaises with Senior Contract Manager to finalize timelines, strategy and plans for contracts in EU and UK for each all clinical study in EU.
• Liaises with Clinical Sites on a regular basis to obtain feedback on contract and budget negotiation according to Senior Contracts Manager instructions.
• Reporting and escalating issues related to negotiation of the clinical trial agreements to Contract Manager in fashionable time and according to the plan agreed with Study Team, SOP and instructions given by Senior Contracts Manager.
• Tracking and monitoring progress and actions related to Contracts and Budgets assigned for each site in each country according to the tools provided for that study, SOP and instructions given by Senior Contract Manager and Study Team and keep weekly tracker for each study up to date on a weekly basis. Assisting Senior Contract manager with the preparation of the country template and country budget for each study in each country according to Senior Contract Manager Instructions.
• Assisting Senior Contract Manager with the direct translation of any document from Italian to English and vice versa.
• Directly reviewing and customizing budget, contract, and amendment according to protocol Synopsis, tools and templates provided by Senior Contract Manager in Italy and UK.
• Assisting the Senior Contract Manager with the revision of budget, contract, and amendment according to protocol Synopsis, tools and templates provided by Senior Contract Manager in the English-Italian countries.
• Building and keeping good relationships with all sites/sites contact. Attending internal study meetings or Sponsor meeting as requested by Senior Contract Manager.
• Working independently with the negotiation of contract and Budget in Italy and UK.

Level of Education

Life Science or Legal degree and experience in budget and contract negotiation in previous CRO or Pharmaceutical Company.

Prior Experience:

2-3 years’ experience in Budget and Contract negotiation in EU and in UK gained in CRO or Pharmaceutical Company
Working in a CRO or pharmaceutical / health related business environment preferred
Working knowledge of Site Contract and/or paralegal background preferred
Previous experience in Contract and Budget negotiation in France in a previous CRO or pharmaceutical Company highly advantage/desire.

Skills and Competencies needed:

Good interpersonal skills.
Highly organized and detail orientated.
Ability to prioritize workload and develop effective processes.
Proficient working knowledge of MS-Word and Excel
Good communication skills verbal and written.
Fluent knowledge of written and verbal English

What we offer:

Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.

This job does not offer company sponsorship