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
Let us introduce ourselves
Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery. Based on two decades of clinical experience and research and development, the company’s Exablate® Neuro platform focuses sound waves, guided by MRI, to provide tremor relief to patients with Essential Tremor and Tremor-dominant Parkinson’s Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions.We are a global team united by a common vision to transform healthcare by making focused ultrasound a standard of care for patients.
Our culture is built on Our Values of integrity, team, quality, innovation and patient care. We challenge and empower our people to be great at what they do and leverage our different ideas, skills, interests and cultural backgrounds to succeed.After a recent investment round, Insightec is valued at more than $1B, bringing it to unicorn status. We are over 350 strong in Haifa and K. Ono in Israel, Miami, Dallas, Shanghai and Tokyo.
Do the most meaningful work of your career by joining us in our mission to make the impossible possible.
Insightec is an equal opportunity employer and is committed to a safe work environment free from discrimination, where employees are treated with dignity and respect. Insightec does not discriminate against any employee or applicant on the basis of race, color, religion, national or ethnic origin, sexual orientation, gender identity or expression, age, disability or other characteristics protected by law. We adhere to these principles in all aspects of employment including hiring.
