Location: Hybrid (2 days onsite California) or Remote
Job Description:
A leading biotechnology company are looking for a Clinical Operations Associate for the drafting, negotiation, and review of site contracts. The role can be hybrid with 2 days onsite at their California location or fully remote. The successful applicant will respond to and resolve complex issues associated with domestic and international contracts with support from more senior staff and Legal department. The ideal candidate will have demonstrated success in working collaboratively with stakeholders, especially senior Clinical Operations management.
Responsibilities include:
- This role can manage the day-to-day activities in complex clinical trials contracts (CTA) and budget negotiation processes
- Assess project performance to monitor the progress of projects, identify and quantify variances, perform required corrective actions and communicate to all stakeholders
- Support management in identification of risks, develop mitigation strategies, alternative solutions, resolve issues, action item/follow up in collaboration with cross functional and/or matrix teams
- Works with Functional Service Provider (FSP) to implement Site Contracts CALM Contracts Process to ensure efficient delivery of fully executed contracts.
- Assess knowledge and/or quality gaps of team to determine and deploy appropriate training plans and/or needs in collaboration with management
Experience:
- 4+ years of experience with a BA in a relevant discipline.
- 3+ years of experience with a MS/MBA in a relevant discipline.
- Experience of contract negotiation and/clinical finance, contract language, budget negotiation.
- Skilled at project management, able to meet deadlines on multiple concurrent projects and work collaboratively with and through others.
- Ability to analyze situations from organizational, departmental perspective (ie considers strategy, culture, structure, systems, people, processes and planning).
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