Clinical Trial Operations Opportunities at Parexel
Clinical Trial Operations
Site Contract LeaderJob ID 61783BR United Kingdom - Any Region - Home Based
- 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)
- 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).
- 1-3Years’experiencein sitecontractnegotiation
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