
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
đŚđˇ Argentina â Remote
â° Full Time
đĄ Mid-level
đ Senior
đˇââď¸ Project Manager
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.
⢠Take overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials ⢠Oversee and coordinate study resources to ensure compliance with budgets, scope, timelines, SOPs, GCP, regulatory and study-specific requirements ⢠Act as the main communication line to relevant stakeholders ⢠Provide input to feasibility, study design and budget development, and ensure progress reporting on resources, budget and timeline ⢠Serve as primary contact for the Sponsor and provide timely trial-progress updates ⢠Lead client calls ⢠Oversee and actively participate in preparation of study plans, protocols, informed consent forms, eCRFs, TLFs and clinical study reports ⢠Participate in planning and conducting Investigator Meetings ⢠Ensure sites have required investigational products, study supplies, equipment and safety lab kits ⢠Lead study start-up, including kick-off, TMF setup, site selection and activation, vendor setup, contracting and budgeting ⢠Collaborate with Regulatory Affairs on submissions and essential documents ⢠Partner with Data Management on CRF alignment, data review, query resolution and database lock timelines ⢠Keep studies audit ready and monitor study, vendor and SubCRO deliverable quality ⢠Manage risks and quality-control measures; analyze planned versus actual results ⢠Review and approve responses to quality assurance audits ⢠Control project budgets and internal hours; identify out-of-scope activities for change orders ⢠Manage clinical-trial timelines, budgets, resources and vendors, coordinating cross-functional tasks and deliverables ⢠Communicate with study teams, functional departments and senior management ⢠Manage and report recruitment status and initiatives ⢠Lead the core project team and ensure project training ⢠Coordinate with Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics and Scientific Affairs ⢠Maintain project-specific training matrices and up-to-date training records
⢠B.Sc. in a related field of study to clinical research ⢠At least 5 years industry experience ⢠Minimum of 3 years in Phase I-III clinical trial project management ⢠Experience managing dermatology and/or rheumatology trials ⢠Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD ⢠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 ⢠Excellent communication skills ⢠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 ⢠Applicants must be legally able to work in Argentina
⢠Flexible work schedule / work schedule ⢠Home-based position ⢠Ongoing learning and development ⢠Attractive advancement opportunities ⢠Equitable treatment and equal opportunity ⢠Accommodations throughout the recruitment and selection process to applicants with disabilities, upon request
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