Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

• Draft, review, negotiate and finalize agreements with study sites in accordance with local/accepted process.
• Negotiate within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with Company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes.
• Ensure compliance to established negotiation parameters, authority approval, contractual process and client expectations.
• Ensure compliance of budgetary guidance, templates and process.
• Identify and assess legal, financial and operational risks in accordance with company and client contractual considerations, and escalates to appropriate level of the organization per established processes.
• Provide recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channels.
• Coordinate with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensure alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation.
• Achieve target cycle times for site activations.
• Ensure guidelines and processes are followed for efficient escalation of out of parameter issues, as applicable.
• Complete tracking and reporting as required.
• May provide training and mentoring to junior staff.
• Participate in country process improvement initiatives, representing Global Site Contract activities within country team meetings.
• Act as country subject matter expert in review of Investigator Contracts training materials.
• Liaise with Global Site Contracts to ensure full compliance with established global processes and corporate directives.
• Complete periodic quality reviews and peer feedback reports.
• May act as lead with amendment/novation client projects and oversight of confidentiality agreement negotiations

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years') or equivalent combination of education, training, & experience.
• Experience in a CRO/Pharma company

• Detailed understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws
• Effective communication skills (verbal and written) in English and Spanish
• Detailed understanding and demonstrated ability to effectively negotiate investigator grant budgets within negotiation parameters
• Strong attention to detail
• Excellent analytical and decision based thinking
• Understanding of the pharmaceutical product development process and involvement of CROs
• Able to work independently or in a team environment
• Good organizational and time management skills
• Working knowledge of PPD SOP and WPDs
• Able to organize competing priorities logically and review outstanding contractual risk and issues
• Able to effectively use automated systems and computerized applications, such as, Microsoft Outlook, Excel, Word, etc.
• Ability to demonstrate a customer focused style of communication, problem solving and collaboration
• Detailed understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws
• Detailed understanding and demonstrated ability to effectively negotiate investigator grant budgets within negotiation parameters
• Demonstrated ability to independently train and mentor Contract Specialists
• Demonstrated ability to provide valuable feedback to Investigator Analysts
• Strong problem solving skills that are demonstrated via solid risk analysis that results in resolution or escalation as appropriate
• Demonstrated ability to effectively negotiate Investigator Contracts in the best interests and position of PPD and client