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.
- Being introduced by an Insightec employee
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