Senior Regulatory Clinical Operations Manager
6 days ago
Lifelancer is a talent-hiring platform that connects professionals with opportunities in the life sciences, pharma, and IT sectors. We offer an open and friendly work environment where our team members can grow and develop their careers.
As a company, we undertake vital clinical studies for sponsors, including leading global biotechs and top pharmaceutical companies. Our pipeline of work is extensive, providing numerous opportunities for career growth and development.
About the Role: Clinical Operations Manager (Regulatory)The Clinical Operations Manager (Regulatory) plays a critical role in ensuring performance and compliance with assigned protocols in a country. This includes adhering to ICH/GCP and country regulations, client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
This role requires extensive experience in local EC and RA submission, including initial submission and protocol amendments submission. The successful candidate must be familiar with XML completion and have skills in independently preparing submissions to both EC and RA.
Other essential skills and qualifications for this role include:
- Experience in ICF preparation using templates
- Knowledge of the local regulatory environment, submissions, and approval processes
- Experience in IMP supplies management at the local level
- Experience in validation of translated documents
We provide a competitive salary package, estimated to be around $120,000 - $150,000 per year, depending on location and experience. In addition to a generous compensation package, we offer a range of benefits, including:
- A dynamic and supportive work environment
- Ongoing training and professional development opportunities
- A chance to work on exciting projects and contribute to the success of our clients
- A collaborative and open-minded team culture
If you are a motivated and experienced professional looking for a new challenge, please visit our website to learn more about this opportunity and how to apply. We look forward to hearing from you
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