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  • 1 week ago

jobs description

Are you looking for an opportunity where you can utilize your medical knowledge to convey scientific data and interact with medical global thought leaders? Are you highly motivated by being able to make a difference in improving patients' lives? If so, we have an exciting Clinical Development Center (CDC) Project Manager opportunity for you. Apply today

About the department
Novo Nordisk is a global healthcare company with 100 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs over 60,000 people in 80 countries, and markets its products in more than 170 countries.

The position
As a CDC Project Manager, you are in charge for managing multiple clinical trials in Korea CDC, ensuring that deliverables are met according to project timelines, within budget, and in... compliance with the protocol, regulatory requirements, International Conference on Harmonization – Good Clinical Practice (ICH-GCP), and Novo Nordisk Standard Operating Procedures (SOPs).
Other tasks include:
• Manage trial activities from site selection to post-trial tasks, including organizing, communicating, conducting feasibility assessments, planning resources, assessing risks, and developing strategies for trial implementation. Serve as a key point of contact for Clinical Research Associate (CRA)s, Headquarter Trial Manager (TM)s, and Therapeutic Area Managers, ensuring timely communication of trial issues and compliance with Novo Nordisk policies. Additionally, be liaible for project timelines, deliverables, and country budget according to ClinCost procedures.
• Provide consolidated country input for document review, manage relationships with local Conversion Rate Optimization (CRO)s and vendors, and ensure regulatory approvals and Clinical Trial Management System (CTMS) updates.
• Monitor recruitment and retention of trial subjects, provide status updates to headquarters TMs, ensure data cleaning milestones, and oversee document filing and compliance with guidelines.
• In charge for escalating issues to local line manager, HQ TM and seeing to consistency between the trial sites and CRAs.
• Proactively drives clinical trial activities forward and delivers results that have a direct impact on the successful completion of the clinical program. In charge for the country budget of the assigned clinical trial(s). Qualifications
• Minimum bachelor's degree in pharmacy, life science or nursing is required.
• Previous experience in trial management and monitoring in clinical trials in accordance with ICH GCP.
• Trial and resource management skills, along with an understanding of clinical trial regulations, as well as excellent knowledge of clinical trial methodology, and up-to-date awareness of the clinical trials environment - including ICH GCP, regulatory issues, and SOPs.
• Completed GCP training and obtained a certificate, with knowledge of the drug development process.
• Computer literacy and IT skills include proficiency in SAP, CTMS, EDC, and eTMF, as well as strong communication skills in English
South Korea

salary-criteria

Apply - CDC Project Manager South Korea