Regulatory/Clinical Project Manager / 社名非公開
|職種||Regulatory/Clinical Project Manager|
・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.
・Builds and sustains extensive global networks across multiple functions at study team level
・Develop and share best practices to accelerate projects timelines
■Job Location and Reporting
・The job is in-house full time position in InSightec Japan. The position will be reporting to Senior Clinical Project Manager， Mr. Martin Bernstein of InSightec-Israel. The Global regulatory and clinical teams report to VP of Global Regulatory and Clinical team.
・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
・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 and CRO subcontractors 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.
・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
|求める経験||■Skills and Qualifications
・Bachelor’s degree required in medical/healthcare-related science related field. Advanced degree preferred.
・6-8 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 and or Korean 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
・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.
|年収||500万円 - 1200万円|