Clinical Operations Manager Regulatory
1 month ago
We are seeking a highly skilled Clinical Operations Manager (Regulatory) to join our team at Lifelancer. As a key member of our organization, you will be responsible for ensuring the performance and compliance of assigned protocols in a country, in accordance with ICH/GCP and country regulations, client policies and procedures, quality standards, and adverse event reporting requirements.
Key Responsibilities:- Extensive experience in local EC and RA submission, including initial submission and protocol amendments submission.
- Independently preparing submissions to both EC and RA, with support from CTC for document collection.
- ICF preparation using templates.
- Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups.
- Experience in IMP supplies management at the local level, including vendors providing background meds and standard of care.
- Validation of translated documents.
We offer a dynamic and supportive work environment where you can develop your skills and advance your career. As a Clinical Operations Manager (Regulatory) at Lifelancer, you will have the opportunity to work on a wide range of projects and contribute to the success of our organization.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT, connecting talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains. Apply now and take the first step towards a rewarding career in Clinical Operations Management.
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