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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.

Position Overview:

As a Site Contract Specialist, you will prepare and negotiate contracts, as well as, finalize the contract process. You will liaise and establish effective relationships with sites and internal functional teams. Ensure quality, objectivity and risk analysis in the efficient delivery of contracts.

Essential Functions:

• 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.

Keys to Success:

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

Knowledge, Skills, Abilities:

• 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.

Why join us?

We hire the best, develop ourselves and each other, and recognize the power of being one team! We understand that you will want to grow both professionally and personally throughout your career, and therefore at you will benefit from an award-winning learning and development programme (https://www.ppdi.com/careers/about#Training) , ensuring you reach your potential.

What we Offer:

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture (https://www.ppdi.com/careers/life-at-ppd) , where we truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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.