Clinical Project Manager_Oncology BU
- Seoul, South Korea
The Clinical Project Manager is the single point of contact and local study team lead for the assigned projects, including regulatory post marketing surveillance, investigator initiated trial and manage access programs. The main activities include communication with CROs, HA, CRA, CTS or In-house CRA and other key country associates such as country medical advisors to assure the delivery of high quality data in accordance with GCP, ICH and local regulations within timeline and budget. The CPM is accountable to communicate with and support relationships with clinical investigators especially studies for RMP PV studies & re-examination.
1. Leads assigned projects of Medical Affairs Clinical Operation team to ensure deliverables are met within the established timelines, budget, drug supply and quality/compliance standard managing CRO and internal/external stakeholders.
2. Manages the whole process of regulatory post-marketing surveillance or non-interventional study with full understanding of local laws/regulations regarding re-examination system to retain product licenses in Korea.
3. Oversees local vendor/CRO performance, including set-up activities, monitoring, budget control, study drug managements, documents aspect of governance through proper CRO selection and set SSW. And support study feasibility and lead to achieve milestone in collaboration with local/region/global medical and CRO. Ensure annual regulatory reports to be submitted to HA & IRBs as required by local regulation.
4. Advises on protocol and CRF from the operational side, and collection and delivery of medical advice for RWE(real world evidence) studies.
5. Ensures operation of managed access programs based on Novartis SOP and local laws/regulations.
6. Leads IIT specialists to administer, maintain and co-ordinate the paperwork of IITs in compliance with Good Clinical Practice (GCP) and relevant Novartis SOPs.
• Minimum 5 years' experience in clinical research, in planning/executing and/or monitoring clinical trials
• A project management and non-interventional studies experience preferred.
• Capable of leading in a matrix environment, without direct reports
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
• A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
• Fluent English (oral and written)
Ability to communication externally in the country native language
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