Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.
As a Site Contract Specialist dedicated to one client, you will prepare and negotiate contracts, as well as, finalize the contract process, whilst fully integrated into the client's systems and SOPs.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Prepares and negotiates contracts, as well as, finalizes the contract process. Liaises and establishes effective relationships with sites and internal functional teams. Ensures quality, objectivity and risk analysis in the efficient delivery of contracts.
- 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 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 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:
- 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 and Abilities:
- 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 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
- Excellent analytical and decision based thinking
- 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 and WPDs
- Able to organize 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
PPD Defining Principles:
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
Please note only short-listed
candidates will be contacted.