Site Contract Leader
- Parexel
- 1 - 3 Years
- Thailand
- 3 years ago
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Job Description
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) 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)
Qualifications
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.
Minimum Work Experience
1-3 Years experience in site contract negotiation
Employement Category:
Employement Type: Full timeIndustry: Pharmaceutical
Functional Area: IT
Role Category: Software Engineer
Role/Responsibilies: Site Contract Leader
Contact Details:
Company: Parexel InternationalLocation(s): Thailand
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Parexel
As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will...
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