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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Site Contract Leader

Job ID R0000002903 Hong Kong, Remote

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The main responsibility of the Site Contract Leader is the negotiation of study specific, generic, site specific and countryClinical Site Agreements(CSA) and any other agreement that is required for the completion of theSite Initiation Visit (SIV). The Site Contract Leader is also responsible for managing CSA activities and liaising with study specific stakeholders to ensure that the CSA start-up deliverables are met.

Key Accountabilities:

  • Act as functional Leader on projects and develop study specific CSA strategy
  • Drafting legal language and creating budgets for CSA negotiations
  • Agree and negotiate study specific CSA templates with the Sponsor and Site as applicable
  • Communicate CSA strategy, CSA turnaround timelines, tracking requirements and budget information/updates with key stakeholders.
  • Coordinate interaction between Parexel study team and Sponsor as applicable to include but not limited to overall timeline management for CSA delivery.
  • Provide updates about template amendments, process changes, investigator fees, local requirements etc. to ensure that relevant CSA database is maintained in real time
  • Early recognition of areas of potential problems and formulate contingency plans
  • Define solutions strategy of significant CSA changes requested by the site
  • Participate in client and team meetings
  • Identify and facilitate CSA training needs as applicable
  • Maintain and assure quality of work generated
  • Prioritize effectively and respond to urgent requests within team or sponsor lead
  • Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, and Parexel SOPs and study specific procedures
  • Complete routine administrative tasks in a timely manner (e.g. Timesheets, metrics, travel expense claims)The main responsibility of the Site Contract Leader is the negotiation of study specific, generic, site specific and country Clinical Site Agreements (CSA) and any other agreement that is required for the completion of the Site Initiation Visit (SIV).

Qualifications :

Minimum Work Experience·: 1-3 Years’ experience in site contract negotiation

Skills

  • Possess strong negotiation, diplomacy, team leadership skills and excellent organizational ability
  • Excellent interpersonal, verbal and written communication skills
  • Ability to motivate both individuals and a team
  • Ability to successfully work in a “virtual” team environment
  • Must have strong analytical skills with the ability to create or interpret legal language and budgets
  • Demonstrate thought leadership and innovation
  • Maintain grace under pressure while displaying a high level of professionalism
  • Align internal and external resources to achieve objectives
  • Attention to detail
  • Work effectively as part of a team
  • Comprehend and interpret contract language
  • Identify problems independently and execute solutions
  • Quickly comprehend desired end-result, goal or objective and act to accomplish
  • Demonstrated effective decision-making
  • Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint
  • Polished presentation skills

Education

  • Degree in business, legal or life science or other relevant
  • Work experience in Contracting, Clinical Operations or in Legal (Paralegal).
  • Language Skills· Fluent in written and spoken English.

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