Global Pharmaceutical Company
Study Manager/ Country Lead Monitor
- All aspects of site management and monitoring activities for assigned applicable Phase I and all Phase II-IV clinical Investigator sites within the approved Clinical Development Plan(CDP). These global, complex studies are conducted within the standards set by the Company Global Development, according to Good Clinical Practices (ICH - GCP) and applicable regulatory and legal requirements.
- Managing Investigator site and site activities and monitoring site data, to ensure patient safety and ethical and regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of drugs.
- Managing Investigator sites to ensure the Investigator and Site Staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out.
- Rigorous regulatory guidelines exist to ensure overall patient safety related to reporting of serious or unexpected adverse drug reactions. The Study Manager / Country Lead Monitor is responsible for training the Investigator and site staff on these strict regulations and procedures for timely reporting and as well as monitoring ongoing compliance. Strict adherence is essential to remain compliant with on time reporting from the Company to regulatory authorities and critical for thorough and timely evaluation of patient safety.
- Due to the highly regulated clinical trial environment, the Study Manager / Country Lead Monitor proactively identifies potential issues and develops site Corrective Actions / Preventive Actions (CAPAs) Plans. The Study Manager / Country Lead Monitors ensures timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data.
- As key contributor to the Trial Master File and study documents at the country level, ensures essential documents are appropriate and filed in a timely manner in the Investigator Site File.
- Incumbent is a key contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections to ensure a successful outcome. The Study Manager / Country Lead Monitor is a member of the audit/regulatory inspection team.
- Due to experience and expertise, the Study Manager / Country Lead Monitor may be a mentor and role model for new or less experienced CRAs on process, study, technical or behavioral competencies. The Study Manager / Country Lead Monitor may also conduct co-monitoring visits as defined in the Study Oversight Plan to mitigate risks and ensure the quality and reliability of study data and processes. In addition, the Study Manager / Country Lead Monitor may participate in Expert Working Groups for Global SOPs, training or process improvement initiatives.
- University degree or above
- At least 6 years experience in the healthcare industry
- 4 years of monitoring & site management experience
- Responsible for site management and monitoring of applicable Phase I and all Phase IIIV complex and global clinical trials
- In-depth knowledge of the drug development process including monitoring and site management, local and international regulations, ICH - GCP, drug safety requirements, data management processes and investigator grant parameters
- Budgement management experience
- Business Level English (TOEIC 730+), Fluent in Japanese
- Awareness and understanding of cultural/ regional operational differences
(Experiences and skills will be considered)
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