Clinical Site Contract Specialist
il y a 2 semaines
Clinical Site Contract Specialist - Netherlands
PPD, part of Thermo Fisher Scientific are currently hiring for a Site Contract Specialist to join our Clinical Operations team in the Netherlands.
This role is vitial in the sucessful start-up of clinical trials in country and can be either home based, Office based in Ede or Hybrid.
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.
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 25 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.
- General understanding of business and financial principles that related to service agreements.
- Effective communication skills (verbal and written) in English and Dutch
- 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.
- 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, ensuring you reach your potential.
What we Offer:
As well as being rewarded a competitive salary, we have an extensive
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