Work Schedule

Environmental Conditions

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.

Join Us as a Site Contract Specialist – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to prepare and negotiate contracts, as well as finalize the contract process. As a Site Contract Specialist, you'll liaise and establish effective relationships with sites and internal functional teams. You will ensure quality, objectivity, and risk analysis in the efficient delivery of contracts.

What You’ll Do:

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.

Education and Experience Requirements:

• 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).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and 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 languages (German required, French preferred, Italian beneficial)

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 competing 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
 

At PPD clinical research services 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 PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

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, where PPD clinical research services 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.