Work Schedule
Other

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.

• Drafts, reviews, negotiates and finalizes agreements with study sites.
• Negotiates 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.
• Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations.
• Ensures compliance of budgetary guidance, templates and process.
• Identifies and assesses legal, financial and operational risks and brings them up to the attention of appropriate level of the organization per established processes.
• Provides recommendations and alternative resolutions to Investigator Contract negotiations through established escalation channels.
• Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed up timelines; ensure alignment of contract negotiation process for sites and study are accurately aligned to the critical path for site activation.
• Achieve target cycle times for site activations.
• Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.

• 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 2-5 years') or equivalent combination of education, training, & experience.

• Understanding of the principles of contract law, including knowledge of laws that influence contract language, such as business, intellectual property and local tax and stamp laws.
• Proven ability to apply basic principles of investigator grant negotiation.
• General understanding of business and financial principles that related to service agreements.
• Effective communication skills (verbal and written) in English and in language spoken at local place of work.
• Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters.
• Strong attention to detail and excellent analytical and decision based thinking.
• Knowledge 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
• Solid understanding of PPD SOP and WPDs.
• Able to coordinate 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.