Thermo Fisher Scientific is a company dedicated to making a positive impact on a global scale through scientific innovation. As a Site Contract Specialist, you will prepare and negotiate contracts for clinical trials, ensuring compliance and quality while establishing effective relationships with study sites and internal teams.
Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process.
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 escalates to appropriate level of the organization per established processes.
Provides recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channels.
Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensures 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.
Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.
Qualification
Required
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)
Good 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
Demonstrated 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 & written) in English and local language
Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters
Demonstrated ability in attention to detail
Excellent analytical and decision based thinking skills
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 & WPDs
Able to organize conflicting priorities logically and review outstanding contractual risk and issues
Able to effectively use automated systems and computerized applications
Ability to demonstrate a customer focused style of communication, problem solving and collaboration
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
Able to work upright and stationary for typical working hours
Ability to use and learn standard office equipment and technology with proficiency
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
May require travel
Preferred
Benefits
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
