Ref #: 33242

Employment type: Fixed term - Full-Time

Location: Netherlands

Posted: 11-Nov-2021

Description

The Senior Site Contract Specialist will be responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of grants and contracts.



Responsibilities include:

• 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 company 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.

Education & Experience

• Academic degree, preference for any background related to Law/justice
• At least a first industry experience, preferably in pharmaceuticals, CRO, or with clinical related activities
• Exemplary customer focus with vision to drive solutions
• Capable of decision making and problem-solving attitude
• Adhere to SOPs, ethics and departmental compliance as determined by management as well as operating companies, corporate, HCC and QA guidelines.
• Able to ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS, GCDO and operating companies. Comply with
requests from QA and auditors.
• Able to work independently as well as in a collaborative team environment.
• Fluent communication skills in Dutch & English



Why this vacancy 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 company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Would you like to know more? Please submit your CV to iris.brouwer@docsglobal.com via our homepage www.docsglobal.com. We are looking forward to your application.