What are the responsibilities and job description for the Clinical Program Manager, APAC position at EPM Scientific?
Salary : $145-165K
Company Summary : One of the best funded pre-IPO biotechs with upwards of half a billion in funding is growing their clinical operations team as they continue to expand their oncology trials on a global scale. With an office in Hayward, they have Nobel prize winning science and experienced former Big Pharma C-suites executives at the helm to back it. Their pipeline has 7 programs in development across 12 indications and their lead candidate is heading into Phase 3. The best fit for this role will be a team leader who has APAC trial management experience and the ability to communicate in a language relevant to the region (Korean or Japanese).
Candidate must be able to go on-site in Hayward, CA three times a week.
The Clinical Program Lead will be responsible for
- Reporting into the Sr. Director or Director of Clinical Operations and working in collaboration with Clinical Ops and Clinical R&D teams.
- Leading and managing Clinical Ops Study Management team and providing direction to cross-functional study teams to ensure successful study execution.
- Ensuring the design, monitoring, data interpretation and reporting activities related to the conduct of clinical studies are conducted in accordance with applicable regulations, ICH / GCP, APAC, PMDA, regulations and Standard Operating Procedures (SOPs).
- Managing ancillary (non CRO) vendor relationships and performance.
- Providing updates on study to internal stakeholders.
- Ensuring accurate and complete filing within clinical / reg / finance / safety systems.
- Complying with internal processes, SOPs, clinical & insurance supply management, and import / export requirements.
A candidate for this role MUST have...
Benefits :
If you are interested in this Clinical Program Manager role, feel free to reach out!
Salary : $145,000 - $165,000