Clinical Project Manager

What you will be doing:

  • Manage clinical studies under assigned indication, therapy and/or geography
  • Lead/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, including 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 the 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 dispersed 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

What you have:

  • Bachelor’s degree in the 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, including formal certifications
  • 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 by peer-to-peer, and site investigators
  • Current working knowledge of regulatory submission process for Israel and Asia as well as clinical trial development from concept through final CSR; familiarity with EU & 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, EU, Israel, and Asia working hours, as appropriate
  • Able and willing to travel internationally, including the ability to receive an international passport, and entry visas and fully comply with entry requirements of geographies in reference.

Advantages:

  • Being introduced by an Insightec employee

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