INSIGHTEC is a fast-growing medical technology innovator transforming patient lives through incisionless surgery.

For thousands of years, surgeons have been cutting away diseased tissue. With INSIGHTEC’s focused ultrasound technology and magnetic-resonance imaging (MRI), sound waves precisely treat deep in the brain. No incisions. Little to no risk of infection. Minimal hospitalization.

The surgeon is equipped with a workstation, keyboard and mouse – no scalpel in sight.

CLINICAL PROJECT MANAGER – JAPAN

General

• • Manage successful Clinical Research and Clinical Trials submissions (as needed) to Japan/Asian leading Hospitals in full compliance with local regulatory laws
  • Manages successful execution of assigned global clinical studies in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), when and where applicable Japan PMDA/MHLW, United States Food and Drug Administration (FDA) regulations/EU Directive, International Conference on Harmonization (ICH) guidelines and any other applicable guidelines and regulations.
  • Responsible for clinical operational oversight and execution of assigned trial(s) in order to achieve successful delivery regarding expectations of quality, timelines and budget, study conduct.
  • Partner with “Clinical Monitoring and QA Manager” to ensure adequate monitoring personnel resources are available and trained, that processes and documentation are consistent across the CRO, and quality checks are in place.
  • Builds and sustains extensive global networks across multiple functions at study team level
  • Develop and share best practices to accelerate projects timelines

Relationships

• • Develop professional relationships with investigational sites and key opinion leaders involved in assigned study(ies) to ensure appropriate stakeholder engagement and support.
  • When applicable, manage relationships with PMDA in collaboration with the local regulatory team, or as needed.
  • Manages relationships and maintains open communication to successfully meet projected trial timelines, trial execution and completion, and projected Clinical Summary Report (“CSR”) and publication commitments.
  • Manages study team performance to ensure adherence to agreed deliverables within timelines. Ensure full compliance with global/local regulations. 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.

Trial Management

• • Hands-on management of assigned clinical trials to ensure that timing of all major trial meets the plan. Coordinates updates, including presentations and communications, on assigned trials to management.
  • Manages site relationships and provides timely input to ensure that trials are executed according to agreed project plan.
  • Works with internal CRO 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.
  • Serves as the key point of contact for operational and process related issues and inquiries for assigned trial(s).
  • Takes specific responsibility to manage quality of clinical trial initiation, execution, recruitment efforts, monitoring activities, and direct database management including and not limited to successful data base lock (DBL) and reporting.
  • Liaise with vendors and internal stakeholders to ensure timely DBL is achieved

Processes & Procedures

• • Manages appropriate implementation, conduct, tracking and reporting of assigned trial(s) including quality review of trial information within Clinical Trial Management System (CTMS) and other systems used to support and manage assigned responsibilities
  • Manages clinical study activities to meet PMDA PMS requirements, including clinical trial report development
  • Identifies and assists with opportunities for process development, improvement and implementation of policies, procedures and processes related to Good Clinical Practice, SOPs, and assigned clinical trial activities

Skills and Qualifications

• • Bachelor’s degree required in medical/healthcare-related science related field. Advanced degree preferred.
  • 5-8 years of regulatory and global clinical trial experience (preferably in medical device industry), with at least 2 to 3 years of executing global feasibility, pivotal and post-approval trials.
  • Preferably, ~ 5 years of experience with PMDA process. Experience with China, Korean, or other Asian countries regulatory processes are welcomed.
  • 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
  • Experience with “in-country” representative function is preferred; Willingness to grow in the position of supporting “in-country” representative function
  • Demonstrates strong database management skills, including and not limited to Excel and Access data import /export management
  • Demonstrated technical competence and experience in design, implementation, tracking and completion of global clinical trials to commercialization with highest standards of quality and GCP and the ability to deliver trials on time and within budget.
  • Knowledge of financial principles in budgeting and tracking of clinical trials and effective management of assigned internal and external resources to achieve successful results.
  • Ability to collaborate, align and manage diverse, global cross-functional matrix teams.
  • Able and willing to travel as needed, including international travel

Knowledge Desired

• • Professional in English is a MUST.
  • Knowledge of global clinical trial processes and regulations (PMDA, FDA, China and South Korea).
  • Understanding of principles, implementation and maintenance of regulations.
  • International regulatory experience
  • Knowledge of global trial planning and management principles, and business processes.
  • 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.

Please click here to apply.