
201 - 500 employees
💊 Pharmaceuticals
🏥 Healthcare
💼 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.
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201 - 500 employees
💊 Pharmaceuticals
🏥 Healthcare
💼 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.
• Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects • Ensure compliance with study budget, project scope, timelines, SOPs, good clinical practices, regulatory and study-specific requirements • Serve as primary contact for sponsors, vendors and internal teams throughout the study • Coordinate tasks and deadlines across departments involved in the project • Oversee project coordinators, SSU team members, RDA and RAC resources, prioritizing site activation activities • Coordinate vendor supplies and services with site activation timelines • Escalate at-risk site activation timelines to Project Manager II • Assist with managing sponsor and stakeholder needs and expectations • Assist with team training and plan project activities and resources • Manage quality of assigned work and deliverables • Provide project status updates to internal and external stakeholders • Reconcile study trackers and analyze discrepancies between planned and actual results • Participate in corrective actions, change control and risk management • Review and assist with drafting project operational plans, processes and manuals • Ensure study documents and deliverables meet applicable country requirements • Oversee site selection, feasibility questionnaires and site qualification visit planning • Monitor patient recruitment and subject status; follow up with sites on recruitment strategy • Participate in Investigator’s Meeting planning and conduct • Coordinate central ethics and regulatory submissions with Regulatory Affairs • Ensure collection and maintenance of essential site documents • Assist with TMF quality reviews and audits for inspection readiness • Support clinical monitoring activities, including CRA training, visit report review, site letters and escalated site issues • Track site visits, project-specific training, monitoring reports, follow-up letters and site issue escalations • Maintain the project-specific training matrix and confirm team training compliance • Support sites with investigational product, study supplies, equipment and safety lab kits • Coordinate with Data Management on CRF compliance, query resolution and data review through database lock • Provide technical, therapeutic and project management expertise for training and process improvement
• B.Sc. in a related field of study to clinical research • At least 3 years of experience in a similar role, including activities related to management of clinical studies in the pharmaceutical, biotechnology and/or CRO industry • At least 2 years experience coordinating activities related clinical trial management • Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations • Excellent knowledge of Microsoft Office suite • Excellent oral and written skills in English; French is an asset • Ability to work in a team environment and establish good relationships with colleagues and sponsors • Good problem-solving abilities • Good organizational skills • Strong ability to carry out different projects and work under pressure while meeting timelines • Experience managing small to medium projects using a disciplined approach to project management • Demonstrated ability to establish and deliver resource-based project plans • Excellent people management skills; experience working with and managing teams in a matrix environment • Must be legally authorized to work in Spain
• Flexible work schedule • Permanent full-time position • Company benefits package • Ongoing learning and development • Attractive advancement opportunities
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