【Shockwave】Associate Director, Clinical Affairs

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https : / / www.jnj.com Job Function : R&D Operations Job Sub Function : Clinical Trial Project Management Job Category : People Leader All Job Posting Locations : Chuo-ku, Tokyo, Japan Job Description : Position Overview The Principal Clinical Research Manager will be responsible for the support and oversight of one or more clinical programs conducted in Japan. The individual will be accountable for multiple clinical studies, including clinical study planning, project management activities, oversight of clinical research organizations (CROs) and other vendors, ensuring alignment between Shockwave Medical Inc.’s (SWMI) Clinical Affairs business unit and local SWMI Japanese teams, and for conducting domestic and global clinical studies in compliance with regulatory standards and in alignment with SWMI business needs. This work is accomplished with minimal oversight, requires frequent contact with internal teams in the US and Japan, with Japanese physician customers / sites and regulatory authorities, and is critical to the success of the business. Essential Job Functions

• Responsible for the day-to-day management of domestic and global clinical studies conducted in Japan for pre- and post-market studies.
• Develop clinical trial documentation, with the US Clinical Affairs team, including clinical trial protocol development, case report form (CRF) development, Investigator’s Brochure, IRB or ethics submissions and site contracts.
• Develop site-training tools and tracking tools, interpret clinical data, and manage investigational sites.
• Manage clinical trial vendors (e.g., CRO, imaging core lab(s), IVRS, central labs, IRB).
• Support the selection of CRO study staff, coordinating CRO staff training and ensuring documentation of training completion.
• Work closely to meet corporate objectives with Japanese peers including Regulatory, Project Management, and Medical Affairs teams.
• Support and manage Japanese physician and site relationships involved in SWMI clinical studies.
• Participate in Investigator meetings with National PIs and study Investigators, as needed.
• Participate in Japanese regulatory meetings associated with clinical studies.
• Coordinate and manage investigational products including accountability and reconciliation.
• Manage training of investigators, site staff, and SWMI clinical staff.
• Represent Clinical Affairs at the internal Japanese project alignment meetings, as needed.
• Manage project timelines and vendor performance to meet departmental and corporate goals.
• Manage study budget and payment process for all clinical trial vendors and study sites.
• Oversee clinical data and adverse events during the study. Working knowledge of safety boards including CEC and DSMB.
• Participate in the review of clinical data including data tables and listings.
• Support development and revision of annual, interim, and final clinical study reports, and clinical sections of pre- or post-market approval submissions.
• Support day to day quality by maintaining GCP compliance, reviewing device complaints, reviewing audit reports and implementing corrective action plans, as needed.
• Other duties as assigned. Requirements
• Bachelor’s Degree in a scientific field of study
• Minimum 10 years’ experience directly supporting clinical research or relevant experience in medical / scientific area. 3+ years in a clinical management role, managing  trials and projects.
• Thorough knowledge of Japanese Good Clinical Practice (J-GCP) is required.
• Knowledge and experience in supporting device pre- and / or post-market clinical studies is required including experience running domestic Japanese and investigational device exemption (CTN and US FDA IDE) trials with subsequent Shonin submission.
• Knowledge and experience working with Japan Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA).
• Ability to travel 10-20% domestically and internationally.
• Ability to work in a fast-paced environment while managing multiple priorities
• Operate as a team and / or independently while demonstrating flexibility to changing requirements.
• Experience with electronic data capture (EDC) systems.
• A basic understanding of peripheral and coronary artery disease, and structural heart therapies is an advantage.
• Must have excellent verbal and written communication skills.
• High attention to detail and accuracy.
• Able to manage multiple project teams. Essential Job Functions
• CRF）、治験担当医師用パンフレット、IRBまたは倫理委員会への申請、治験実施施設との契約など、臨床試験関連文書の作成。
• CRO、画像コアラボ、IVRS、中央研究所、IRBなど）。
• CRO治験スタッフの選定をサポートし、CROスタッフのトレーニングを調整し、トレーニング修了の文書化を確実にする。
• SWMIの臨床試験に関与する日本の医師や施設との関係をサポートし、管理する。
• PIや治験責任医師との治験責任医師会議に参加する。
• SWMI臨床スタッフのトレーニング管理。
• CECおよびDSMBを含む安全性委員会の実務知識。
• GCP遵守の維持、機器に関する苦情のレビュー、監査報告書のレビュー、必要に応じて是正措置計画の実施により、日々の品質をサポートする。
• Requirements
• 10年以上の経験、または医療／科学分野での関連経験 臨床管理職として3年以上の臨床試験やプロジェクトの管理経験。
• J-GCP）に関する十分な知識があること。
• CTNおよび米国FDA IDE）試験の実施とその後の承認申請の経験を含む、デバイスの市販前および／または市販後臨床試験のサポートに関する知識と経験が必要。
• PMDA）との協働に関する知識と経験。
• 10～20％の国内外出張が可能な方。
• EDC）システムの使用経験。