Clinical Project Manager

What you will be doing:

  • Responsible for managing clinical studies under assigned indication, therapy and/or geography
  • Manage all aspects of clinical studies from initiation through delivery:
    • Contribute to the development and revision of study documentation including protocols, ICFs, designing CRFs, clinical study reports and protocol amendments.
    • Create study materials and plans at study start-up, including the clinical monitoring plan, case report forms (CRFs), the CRF completion guidelines, the data management plan, recruitment materials.
    • Support the database build /testing and lead the data management and review throughout the study conduct.
    • Enter and maintain clinical trial registration per applicable regulations (Clinicaltrials.gov)
    • 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.
    • Conduct site initiation/closeout activities per company SOPs.
    • Perform and document study protocol training for internal stakeholders and site personnel
    • Coordinate and lead study team meetings and update timelines and milestones as needed
    • Develop recruitment strategies with study sites to meet study enrollment goals
    • Track all patient recruitment and treatments; work with CRAs to address all site compliance issues, data issues, and safety issues; elevate issues as needed to Clinical Affairs management.
    • Work with CRAs to ensure that all sites are current with data entry and routine data reviews are conducted to ensure data quality
    • Review and code safety events and prepare for routine and ad-hoc DSMB meetings
    • Perform annual safety review in preparation for annual regulatory reporting requirements as needed according to internal processes
    • Ensure all project goals are met per timeline and budget.
    • Review and process clinical trial invoices according to internal procedures
  • Support 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 as assigned
  • 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
  • Support trials across a geographically diverse environment (US, Europe, Israel, Asia) that supports cross-functional team effectiveness and promotes efficiencies
  • 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), ISO14155, and FDA regulation
  • Approximately 4 to 6 years of relevant experience in clinical studies management
  • Minimum 3 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
  • Understanding of data management skills, including descriptive data analysis, consistent with the need for report preparation.
  • Able and willing to travel as needed, including international travel

 

Start Your Application

A Better Tomorrow
Starts Here

Discover the transformative power of incisionless focused ultrasound.

Start a Transformation
Skip to content