
201 - 500 employees
đ Pharmaceuticals
đĽ Healthcare
đź Consulting
Pharmaceuticals ⢠Healthcare ⢠Consulting
Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.
đĽ 0 minutes ago
đŞđ¸ Spain â Remote
â° Full Time
đĄ Mid-level
đ Senior
đĽ Clinical Operations
đť Ghost score 12%
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201 - 500 employees
đ Pharmaceuticals
đĽ Healthcare
đź Consulting
Pharmaceuticals ⢠Healthcare ⢠Consulting
Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.
⢠Manage an assigned team of permanent and contracted Clinical Operations staff, including CRAs/cCRAs and Clinical Operations Support personnel ⢠Oversee staff performance and training, team resources, and project resource allocation ⢠Ensure clinical monitoring activities meet sponsor expectations, quality and timeliness requirements, budget, SOPs, regulations, good clinical practices, and study-specific requirements ⢠Implement professional development, coaching, mentoring, and performance evaluations ⢠Assist in developing and delivering Clinical Operations training ⢠Track operational metrics, site visits, utilization, deliverable timeliness, timesheets, expenses, and required training ⢠Perform Quality Assessment Visits with CRAs ⢠Identify quality issues through project meetings, site and team communications, reports, QAVs, and audit findings; establish corrective action plans ⢠Serve as a point of contact and management escalation contact for Clinical Operations personnel, sites, project teams, and sponsors ⢠Assess and interview potential Clinical Operations candidates ⢠Drive innovation, workflow optimization, efficiency, quality, scalability, and adoption of emerging technologies and AI-enabled solutions ⢠Foster innovation, collaboration, and proactive problem-solving across Clinical Operations teams ⢠Conduct on-site or remote monitoring visits as needed ⢠Review site visit reports and metrics, provide input on Clinical Operations plans and tools, and review related SOPs and tools ⢠Support site survey activities and synthesize insights for continuous improvement ⢠Perform other assigned responsibilities when appropriately experienced, qualified, and/or trained
⢠Experience and qualifications sufficient to manage assigned permanent and contracted Clinical Operations staff ⢠Knowledge of clinical monitoring activities and their execution in accordance with SOPs, regulations, good clinical practices, and study-specific requirements ⢠Ability to oversee performance objectives, remedial actions, professional development, and performance evaluations ⢠Ability to support training, coaching, mentoring, and consistent use of study tools and training materials ⢠Ability to track Clinical Operations metrics and monitor adherence to targets ⢠Ability to ensure monitoring expenses comply with policy and established guidelines ⢠Experience performing Quality Assessment Visits (QAV) with CRAs ⢠Ability to identify and address quality issues and establish corrective action plans ⢠Ability to serve as a management contact for sites, project teams, and sponsors ⢠Ability to assess and interview potential Clinical Operations candidates ⢠Ability to identify workflow optimization opportunities and support emerging technologies and AI-enabled solutions ⢠Required experience, qualifications, and/or adequate training for other assigned responsibilities ⢠Applicants must have a work permit for Spain
⢠Flexible work schedule ⢠Permanent full-time position ⢠Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities) ⢠Ongoing learning and development ⢠Attractive advancement opportunities
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