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.

Location/Division Specific Information

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.

Discover Impactful Work:

As a Site Contract Specialist you will prepare and negotiate contracts, as well as, finalize the contract process. You will also liaise and establish effective relationships with sites and internal functional teams. You will be responsible for ensuring quality, objectivity and risk analysis in the efficient delivery of contracts. 100% Remote position.

A day in the Life:

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.

Keys to Success:

Education

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years).

Knowledge, Skills, Abilities

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.

Physical Requirements / Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

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.

Compensation and Benefits

The salary range estimated for this position based in North Carolina is $60,000.00–$90,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards