Senior Clinical Operations Coordinator
hace 1 semana
Key accountabilities of this role include:
- Developing study-specific CSA strategies and agreements with sponsors
- Negotiating study-specific generic and country CSA templates with sponsors
- Supporting project leads in the negotiation of country budgets with sponsors
- Managing CSA activities, including coordination with project leads, GRO leads, and sponsors
- Providing CSA templates to local CTS/CRA for country-specific adaptation
- Coordinating overall CSA process with assigned CTS/CRA and status reporting to GRO-Lead/PL
- Ensuring compliance with applicable ICH-GCP guidelines, local regulatory requirements, and PAREXEL WSOPs and study-specific procedures
Requirements:
- Experience as a CRA, CTS, or senior person with a legal or business degree or other relevant experience, preferably in one of the following environments: contracting, clinical operations, legal (paralegal), or in a comparable function in another CRO or pharmaceutical company
- Global site contract lead experience
- Excellent computer and internet skills, including excellent knowledge of MS-Office products such as Excel, Word
- 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
- Ability to complete tasks in an accurate, timely manner and effectively manage multiple tasks
- Show commitment to and perform consistently high-quality work
- Ability to identify and address issues proactively in a timely manner
- Ability to take initiative, work independently, and delegate
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 and German languages are essential
Estimated salary: $70,000 - $90,000 per year, depending on experience and qualifications.
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