Ref #: 28245

Employment type: Permanent - Full-Time

Location: Russia

Posted: 07-Apr-2021

Description

Services Overview:
Prepare, negotiate and finalize agreements and budgets 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 site/investigator budgets and contracts
Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, etc.
• 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.
• Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate.
• Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and the J&J pricing guidelines. Participate in and/or lead approval escalations as appropriate.
• 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 CCS team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS 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.
• CCS management and functional CCS support teams such as, legal, Healthcare Compliance (HCC), Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
• Track all aspects of legal document and metrics. 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.
• Adhere to SOPs, ethics and departmental compliance as determined by GCDO management as well as operating companies, corporate, HCC and QA guidelines. 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.
• Full utilization by timely and accurate time reporting (BEACON).
• If applicable, region specific deliverables will be specified.
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. SATS) according to expectations (metrics) and archiving retention requirements.
• Ensure inspection ready and comply with relevant training requirements and developing therapeutic knowledge to ensure service delivery.
• Advanced:
o Analyze 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 following corporate process, systems, and strategies.
o May mentor, champion, or represent functional area in process initiatives, as required.
.• Bachelor’s degree in appropriate scientific or business disciplines
• 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.).
• Familiarity with clinical research processes.
• Ability to work effectively in cross function teams.
• Able to work independently as well as in a collaborative team environment.
• Strong and proven negotiation and problem resolution skills.
• Working knowledge of PCs (MS Office suite at a minimum) and database management.
• Fluency in English.

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