Ref #: 32632

Employment type: Permanent - Full-Time

Location: Poland

Posted: 29-Sep-2021

Description

POSITION SUMMARY
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 in EMEA region. Provide support to the clinical team in the pricing, planning, execution and control of grants and contracts.

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 Sponsor's 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 C&G 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 C&G team and support functions and communicate such to stakeholders. Liaise with C&G management and functional C&G support teams, legal, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
*Assume responsibility for all aspects of legal document and metrics tracking. Determine potential needs for contract amendments and manage amendment lifecycle.
*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.

Requirements:
*At least Bachelor’s degree in Life Science or Law degree
*At least 3- 5 years experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research
*Must have a working knowledge of the clinical development process with at least three years of negotiation and contract experience on the international level (experience in vendor oversight is an asset)
*Excellent communication skills (both oral and written)
*Ability to work effectively in cross function teams
*Strong and proven negotiation and problem resolution skills
*Fluency in English is required
*Must demonstrate innovative spirit, have strong interpersonal skills, and ability to accomplish substantial tasks with minimal supervision
*Previous experience working in virtual teams preferred
*Office-based or HB (any location) in Poland

If you have the right skills and experience, please send your CV to dagmara.drozdowska@docsglobal.com