Medtronic
healthcare technology
SrClinicalResearchSpec
“Sr Clinical Research Spec at Medtronic. Skills: Clinical trial monitoring, GCP knowledge, Team leadership, Site management, Regulatory compliance. Planning, execution, progress management, and report writing for clinical trials, post-marketing clinical research, and post-marketing surveillance. Procedural tasks, monitoring, and audit response at assigned sites”
What You'll Achieve.
Ensuring the safety and reliability of clinical trials; Supporting efficient trial operations compliant with Japanese regulations; Optimizing the trial environment through strong relationships with clinical trial sites; Ensuring compliance with regulatory requirements and ethical standards; Contributing to value creation based on scientific evidence; Prioritizing patient safety
Industry & Context.
Excellent problem-solving skills
Ability to travel for business trips involving overnight stays and sudden external work, Ability to participate in global meetings early in the morning or late at night, Ability to respond quickly to serious adverse events, Ability to respond promptly to serious adverse events
What They're Looking For.
Must Have
7+ years of clinical trial monitoring experience in a medical device company, pharmaceutical company, or CRO, Experience leading a team of 3 or more monitors, Experience managing sites at core hospitals such as university hospitals, Deep knowledge of GCP, Ability to read SOPs and work-related documents in English and create monitoring reports, High compliance awareness and quality awareness, Excellent communication and problem-solving skills, Ability to think proactively and act autonomously, Ability to value teamwork and collaborate to complete tasks, Proactive learning attitude, Bachelor's degree or higher (preferably in medicine, pharmacy, nursing, life sciences, or engineering fields)
Nice to Have
Experience in cardiovascular or cardiac vascular fields, Experience in KOL management in the disease area of the assigned trial (including monitoring at KOL facilities), Experience with PMDA face-to-face consultations in a role, Experience with PMDA responses in a regulatory application, Knowledge of ISO 14155
What You'll Do.
and report writing for clinical trials
post-marketing clinical research
and post-marketing surveillance
and audit response at assigned sites
Creation and review of related documents
Reporting and responding to serious adverse events and deviations
Reporting and responding to medical device malfunctions
Leading monitor teams for assigned trials
Teaching and coaching junior or less experienced monitors
How You'll Work.
Team & Collaboration
Building good relationships with internal and external stakeholders; Working collaboratively with the CRMS department; Teaching and coaching junior monitors
Communication Scope
Excellent communication skills; Building good relationships with internal and external stakeholders
Process & Methodology
Progress tracking, Risk management
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