Site Contract Specialist (Home- or office-based)

PPD Romania SRL - 1 poziție
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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 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 Senior Site Contract Specialist you will manage the preparation, negotiation and finalization of the contract process.

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.

Summarized Purpose:
  • Manages the preparation, negotiation and finalization of the contracts process. Liaises and establishes effective relationships with sites and internal functional teams. Ensures quality, objectivity and risk analysis in the efficient delivery of Investigator Contracts.

Please be informed that the Site Contracts Specialist position is offered on a 12-month fixed-term contract.

Essential Functions:
  • 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 in accordance with company and client contractual considerations, 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.
  • Achieves target cycle times for site activations.
  • Ensures guidelines and processes are followed for efficient escalation of out of parameter issues, as applicable.
  • Completes tracking and reporting as required.
  • May provide training and mentoring to junior staff.
  • Participates in country process improvement initiatives, representing Global Site Contract activities within country team meetings.
  • Acts as country subject matter expert in review of Investigator Contracts training materials.
  • Liaises with Global Site Contracts to ensure full compliance with established global processes and corporate directives.
  • Completes periodic quality reviews and peer feedback reports.
  • May act as lead with amendment/novation client projects and oversight of confidentiality agreement negotiations

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 5+ years’) or equivalent combination of education, training, & experience.
  • Experience in a CRO/Pharma company

Knowledge, Skills and Abilities:
  • Detailed 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
  • Effective communication skills (verbal and written) in English and Spanish
  • Detailed understanding and demonstrated ability to effectively negotiate investigator grant budgets within negotiation 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
  • Detailed 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
  • Detailed understanding and demonstrated ability to effectively negotiate investigator grant budgets within negotiation parameters
  • Demonstrated ability to independently train and mentor Contract Specialists
  • Demonstrated ability to provide valuable feedback to Investigator Analysts
  • Strong problem solving skills that are demonstrated via solid risk analysis that results in resolution or escalation as appropriate
  • Demonstrated ability to effectively negotiate Investigator Contracts in the best interests and position of PPD and client

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 .

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Diversity Statement
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
Publicat 13 mai 2022 Expiră 12 iun. 2022
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