Responsibilities:

• Responsible for managing clinical studies under assigned indication, therapy and/or geography
• Leads/direct/coordinate all aspects of clinical studies from initiation through delivery:
  • Assist in writing clinical trial documents including protocols, ICFs, designing CRFs, clinical study reports and implementing amendments.
  • Site onboarding to include site qualification, contract negotiation/budgeting and IRB/EC approval for the study; ensure all regulatory documentation is collected and current during the study.
  • Create all study documentation for study startup, to include the clinical monitoring plan, the CRF guidelines, the data management plan, and support the database build /testing and document all steps in CTMS and RACI
  • Perform and document internal stakeholders and study site study training
  • Support participating clinical site startup regulatory process
  • Track all patient recruitment and treatments within CTMS; work with monitors/CSMs to address all site compliance issues, data issues, and safety issues; elevate issues as needed to Clinical Affairs management.
  • Ensure that all sites are current with data entry and conduct routine data reviews to ensure quality of data.
  • Ensure all project goals are met per timeline and budget.
  • Conduct site initiation/closeout activities per company SOPs.
• Implementation of strategy, scope, process, and programs related to clinical trials within assigned geographies
• Clinical Research and Clinical Trials submissions (as/where needed) to governing Regulatory Agency(ies) in full compliance with local regulation and laws.
• Provide significant and positive impact to short-term, mid-range, and long-term organizational goals
• Manage relationships with external site personnel, vendors, key opinion leaders, sub-contractors and applicable regulatory agencies
• Active participation in the Global Clinical Affairs team activities ranging from SOP development / review to global planning of clinical activities to demonstrate continual improvement in product/system development related matters
• Work within a geographically disperse environment (US, Europe, Israel, Asia) that supports cross-functional team effectiveness and promotes efficiencies
• Support R&D efforts to assist in aligning with clinical trial needs
• Other roles/responsibilities defined as needed

Skills and Experience:

• Bachelor’s degree in life science field. Advanced degree preferred.
• Professional English is a MUST, additional languages are preferred.
• Working knowledge of Good Clinical Practices (ICH GCP) and ISO14155
• Minimum of 3 years of relevant experience in clinical studies management
• Minimum 5 years of global regulatory/clinical trial experience in the medical device industry including experience executing feasibility, pivotal and post-market approved device trials
• Professional presentation capabilities directed peer-to-peer, and site investigators
• Current working knowledge of regulatory submission process for European countries and Asia as well as clinical trial development from concept through final CSR; familiarity with US clinical trial regulations and processes desired.
• Understanding of data management skills, including descriptive data analysis, consistent with the need for report preparation.
• Ability to work remotely and independently and is self-motivated
• Ability to accommodate US, Europe, Israel and Asia working hours, as appropriate
• Computer/keyboarding skills and familiarity with Microsoft Office products (e.g., Outlook, Word, Excel, Powerpoint, Sharepoint, TEAMS, and Adobe Acrobat).
• Ideal candidate will reside within Europe with easy access to travel options; Able and willing to travel as needed, including international travel

Successful candidate(s) will be required to comply with Insightec’s Vaccination Policy.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender/gender identity, age, disability, marital status, sexual orientation, national origin, veteran status, and any other legally protected status entitled to protection under federal, state, or local anti-discrimination laws.