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

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