Senior Clinical Operations Specialist
2 weeks ago
As a Senior Trial Master File (TMF) Lead, you will be responsible for ensuring compliance with ICON values by embracing and contributing to the company culture of excellence and process improvement.
You will develop and implement TMF specifications aligned with program strategies and milestones, assist in responses to regulatory authorities regarding documentation management for audits, questions, and issues, review data quality and audit outputs to identify trends and ensure consistency across programs.
Additionally, you will ensure consistent use of standardized processes and systems across all clinical trials, identify and implement continuous improvement opportunities to enhance operational efficiency, serve as a point of contact for internal and external audits related to study TMF queries, support the preparation of audit and inspection responses, provide guidance and support to the TMF Owner Group to drive performance and resolve guidance conflicts, educate and mentor team members on good document management practices for clinical trials.
Required Skills and Qualifications:- Excellent communication and project management skills
- Ability to work effectively in a fast-paced environment and adapt to changing priorities
- Strong analytical and problem-solving skills
- Competitive salary packages and annual bonuses based on performance
- Comprehensive health-related benefits and retirement plans
- A supportive environment that encourages personal fulfillment and drives lasting change
At ICON, we are dedicated to creating a work environment that is rewarding, challenging, and fun. We strive to attract, retain, and develop top talent from diverse backgrounds, cultures, and perspectives. Our goal is to make ICON a great place to work where everyone has the opportunity to grow professionally and personally.
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