Jobs at Parexel
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 LeaderJob ID 84494BR Philippines, 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 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.
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)
Experience in site contract negotiation
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
Degree in business, legal or life science or other relevant work experience in Contracting, Clinical Operations or in Legal (Paralegal)
Fluent in written and spoken English
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