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Site Contract Specialist, Start Up Team - Denmark

Job Description

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Our goal-driven teams combine and deliver start-up 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 start up timelines and exceed expectations. We have a new vacancy in our growing Start Up Team in Denmark for Site Contract Specialist . This role can be office based in Copenhagen or fully home based in Denmark. As a Site Contract Specialist, you will prepare and negotiate contracts, as well as, finalize the contract processAt 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. Overview: 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. Key responsibilities:
  • 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.
  • There may also be an opportunity to work on Submissions and some Start Up CRA activities
  • Job Qualification

    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 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
  • 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
  • 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

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