Clinical Project Manager, Japan
- Manage successful execution of assigned clinical studies in adherence to Insightec Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), International Conference on Harmonization (ICH) guidelines, applicable Japan GCP and PMDA/MHLW regulations governing clinical trials, and any other applicable guidelines and regulations.
- Responsible for clinical operational oversight and execution of assigned projects in order to achieve successful delivery regarding expectations of quality, timelines, budget, and study conduct.
- Manage site relationships, project overview and provide timely inputs to ensure that trials are executed according to agreed project plan.
- Manage internal company relationships and maintain open communication to successfully meet projected trial setup timelines, project execution phase and completion.
- Hands-on management of assigned clinical trials to ensure that timing of all major trial milestones meets the plan. Specifically, tracks and evaluates trial milestones and monitors overall operational performance metrics through life of the trial. Identifies issues early and proposes and tracks solutions. Whenever possible, resolves issues that have been escalated and/or take issues to management.
- Works with internal Clinical and Regulatory Affairs teams to ensure trial risk assessment is complete, and that mitigation and contingency measures are prepared and implemented. Actively assesses potential risks to trial and implements mitigation plans, as needed.
- Manage and/or supervise and support clinical research activities delegated to local CRO vendors and/or performed by local sites in Japan in site-initiated fashion. Any support of such activities will be performed strictly and in full compliance with Japan GCP regulation, PMDA/MHLW ordinances and Insightec Standard Operating Procedures.
- Serve as the key point of contact for operational and process related issues and inquiries for assigned trial(s).
- Take specific responsibility to manage execution and recruitment efforts.
- Responsible for written regulatory/clinical communications for assigned trials, including, but limited to protocol and CRF modifications and translations/back translations, annual reports with safety reporting, SAE/UADE reports, final Clinical Study Reports, and other internal reports as needed.
Skills and Experience:
- Bachelor’s degree required in medical/healthcare-related science field. Advanced degree preferred.
- 2-3 years of experience in management of regulated interventional medical device clinical trials in Japan.
- At least 3 years of experience in CPM position hands-on managing device studies is a requirement.
- Demonstrates strong database management and data processing & analysis skills, including and not limited to Oracle Clinical and/or Medidata/Rave and/or Medrio and Excel data import /export management and descriptive data analysis.
- Knowledge of financial principles in budgeting and tracking of clinical trials and effective management of assigned internal and external resources to achieve successful results.
- Proficiency in English is a MUST.
- Knowledge of GCP and clinical trial process and regulation in Japan, medical device preferred.
- Understanding of principles, implementation and maintenance of regulations.
- Demonstrates current working knowledge of all phases of clinical trial development from concept through final CSR and knowledge of operational and regulatory processes involved with clinical trials.
- Approximately 50% travel that will vary over time, mainly domestic and including some limited international travel as well (e.g. Japan, China, Taiwan, USA, South Korea, Israel - able to obtain international passport and necessary entry Visas).
- Willing to become an integral part of and collaborate with multinational and multicultural team of clinical research professionals.
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