Ref #: 25137

Employment type: Permanent - Full-Time

Location: Russia

Posted: 16-Nov-2020

Description

Services Overview:
Provide services in the creation and maintenance of Clinical Trial Agreements, Confidentiality Agreements and negotiation guidelines, services in the development of training related to Clinical Trial Agreements, Confidentiality Agreements and negotiation guidelines as required. Lead/support on the review and negotiation of customized and complex templates. Expedite contract negotiation and execution by acting as resource for first line negotiators to streamline requests to law department and avoid duplication of efforts among negotiators. Coordinate with legal department to resolve complex legal issues while ensuring compliance with company process and strategy and subsequently disseminating information to negotiators.

Deliverables:
• Services rendered will adhere to applicable company SOPs, WIs, policies, local regulatory requirements, etc.
• Support creation and maintenance of contract templates in accordance with changes in laws, regulations, or corporate policies.
• Support creation and maintenance of fallback language and negotiation guidelines related to contract templates.
• Support training on contract templates and fallback language and provide training to first line negotiators and others as required.
• Provide specialized support and guidance on the negotiation of CTAs and CDAs to first line negotiators.
• Work with the legal department to create risk assessments to support the decision‐making process.
• Assess risks of legal terms and conditions independently and communicating them to stakeholders such as clinical team, law department, and internal team where appropriate. Provide guidance to 1st line negotiators, stakeholders and others as required.
• Lead negotiations on Master Agreements and custom templates or those requiring extensive modifications and identify potential risks to the business.
• Lead contract negotiations on terms and conditions of high‐risk and complex agreements and other relevant legal documents as they relate to clinical trials and company/departmental policies.
• Coordinate with cross‐functional departments to ensure consistency and compliance with process, external communications and policies.
• Assist in coaching/mentoring staff members.
• Liaise with all members of clinical team as needed in addition to representatives of investigator sites, academic research organizations, contract research organization, and site management organizations as directed.
• Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as determined by GCDO management as well as R&D companies, corporate, HCC and QA guidelines.
• Collaborate with internal stakeholders to ensure proper dissemination and management of knowledge.
• Monitor departmental processes to ensure compliance with corporate policies.

Metrics/KPIs:
• Metrics/KPIs governing these services are outlined in the QOP document.

Interfaces – Primary/Other:
• Primary interfaces: Provider Functional Manager, Company Point of Contact, Company Business Partners (CCS, TA, MAF, MAO, GCDO, JRP, HCC, Risk Management, Legal, etc.).
• Other Interfaces: Clinical Investigator Sites, Principal Investigators, Clinical Research Organizations (when applicable).

Education and Experience Guidelines:
• Juris Doctor (JD) degree, Master of Laws (LLM) degree, paralegal degree, or local equivalent.
• 5 years’ experience with contract law in the pharmaceutical/clinical research industry and/or equivalent competencies in relevant fields with demonstrated ability to conduct contract negotiation, legal research and analysis.
• Working knowledge of the clinical development process.
• Fluency in English.
• Excellent oral and written communication skills and sensitivity to cross‐cultural communication.
• Strong relationship management skills and experience.
• Strong ability to work across different geographic regions.
• Ability to work effectively across all levels of management.
• Strong and proven issue identification and problem resolution skills.
• Sense of urgency with ability to manage competing priorities while meeting deadlines.
• Working knowledge of PCs, MS Office, and database management.
• Business acumen and complex project management skills.
• Demonstrate strong interpersonal and leadership skills with a strong drive to mentor and coach team members.