Job Summary
a drug development company and clinical research organization is searching for a person to fill their position for a Remote Operations Senior Manager.
Candidates will be responsible for the following:
- Processing, maintaining and archiving all essential documents in compliance with the relevant Standard Operating Procedures (SOPs), country regulations and industry best practice
- Assisting to guide the strategy and leading the delivery of department objectives in ensuring the management of the essential documents
- Fulfilling the "Trial Master File (TMF) Approver" and/or "TMF QC Reviewer" roles as defined by the relevant SOPs, as well as performing the role of the "TMF Process Owner"
Skills and Requirements Include:
- Combination of education plus 8-11 years of relevant experience
- In depth knowledge of ICH GCP
- Experience supporting GCP inspections (e.g., FDA, PMDA, EMA, Bfarm, MHRA, etc.)
- Experience of Document Management and/or eTMF solutions (e.g. Veeva, Trial Interactive, Documentum, etc.)
- Ability to provide compliance and quality oversight of TMF processes
- Ability to influence key personnel via a matrix organization
