Ref #: 29350

Employment type: Permanent - Full-Time

Location: Italy

Posted: 03-Jun-2021

Description

Key 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.
* Responsible for delivery against established targets/measurements.
* 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 with the global C&G team as necessary to review and analyse contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the C&G team and support functions. Escalate issues as appropriate.
* 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.
*Adhere to SOPs, ethics and departmental compliance as determined by departmental management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and appropriate corporate processes.
* Comply with requests from QA and auditors.

Profile:

* Bachelor's degree in appropriate scientific or business discipline
* 3 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 (HIPAA, FCPA, Safe Harbor, etc.) a plus
* Working knowledge of PCs (MS Office suite at a minimum) and database management
* Fluency in English is required
* Previous experience working in virtual teams preferred

Why join the DOCS team at ICON?

Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.