Are you passionate about improving patients' lives? This Clinical Research Manager position offers a unique opportunity to contribute directly towards clinical operations and make a difference in the lives of people living with diabetes and other serious chronic diseases.
About the Department
The Clinical Development and Medical Department provides timely, accurate, and updated scientific expertise to drive business services for Novo Nordisk in all therapeutic areas. Our working environment is characterized by interesting and demanding assignments and continuous professional development opportunities.
The Position
Clinical Research Manager (CRM) oversees the implementation of clinical trials, including site selection, application to Institutional Review Board (IRB), delivery of clinical supplies, monitoring, data collection, and site closure, all in compliance with Good Clinical Practice (GCP) and other regulations.
Key responsibilities include:
- Managing team members, ensuring they receive on-the-job training and meet quality standards.
- Organizing study teams, collaborating with project teams to create project plans, designing protocols, and translating documents into Japanese.
- Preparing clinical trials, conducting trials, collecting data, and performing quality checks on schedule.
- Identifying delays and their solutions, advising and instructing staff, and creating Clinical Trial Reports.
- Coping with internal audits, GCP inspections, and paper reviews, estimating clinical budgets, and submitting notifications to regulatory bodies.
Qualifications
- Minimum 10 years of experience in clinical operations, working on GCP clinical trials as CRA or TM.
- Experience in entire Clinical Trial Process from Site selection until Trial Closure.
- Communicational level English and native-level Japanese required.
- Excellent communication and presentation skills for smooth communication with global teams and stakeholders.
Salary
$120,000 - $150,000 per annum
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