Job Description

　　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.

　　Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

　　We are currently seeking a Site Contract Specialist to join our Clinical Operations team who will prepare and negotiate contracts, as well as finalise the contract process.

　　A day in the Life:

　　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

　　Education and Experience

　　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

　　Knowledge, Skills, Abilities

　　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/Client 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

　　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

　　Benefits

　　We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.