Ref #: 33520

Employment type: Permanent - Full-Time

Location: Belgium

Posted: 12-Nov-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 or via oversite of a Clinical Research Organization responsible for contract negotiations.
* Responsible for delivery on established targets/measurements. Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
* Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
* Analyze investigator grants for fair market value aligned with regional knowledge and the grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate.
* Work with the global CCS team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions and communicate such to stakeholders. Liaise with CCS management and functional CCS support teams, legal, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
* Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. Mentor and train new contract coordinators and analysts.
* Assume responsibility for all aspects of legal document and metrics tracking. Determine potential needs for contract amendments and manage amendment lifecycle.
* Exemplary customer focus with vision to drive solutions


Required experience and qualifications:

* A minimum of a BA/BS degree is required. A degree in legal or health or science related fields is preferred.
* A minimum of 2 years of clinical experience is preferred.
* Specific therapeutic area experience may be required depending on the position.
* Strong working knowledge of standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
* Strong IT skills in appropriate software and company systems.
* Proficient in speaking and writing in Dutch and English, with French a strong plus.
* Good written and oral communication skills.



Why this role is right for you:

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a companies dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.



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.



Interested? Please submit your CV via www.docsglobal.com, or ken.falorni@docsglobal.com