
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.
đ August 21
đŠđŞ Germany â Remote
â° Full Time
đĄ Mid-level
đ Senior
đˇââď¸ Project Manager
đť Ghost score 25%
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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, project scope, timelines, SOPs, GCP, regulatory, and study-specific requirements ⢠Act as the main line of communication to relevant stakeholders ⢠Provide input into feasibility, study design, and budget development ⢠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 participate in preparation of study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports ⢠Participate in planning and conducting Investigatorâs Meetings ⢠Ensure sites have necessary study materials and supplies ⢠Lead study start-up activities, including trial 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 assigned studies audit ready ⢠Monitor study deliverables and address quality issues ⢠Manage risks and control measures ⢠Analyze discrepancies between planned and actual results ⢠Review and approve responses to quality assurance audits ⢠Control project budgets and identify out-of-scope activities for change orders ⢠Manage trial timelines, budgets, resources, and vendors ⢠Coordinate tasks and deliverables across functional departments ⢠Communicate with study teams, functional departments, and senior management ⢠Manage and report recruitment status ⢠Lead the core project team and ensure adequate project training ⢠Coordinate with vendors and internal teams to complete tasks and deliverables on time and according to applicable standards ⢠Define and maintain the project-specific training matrix and keep training records current
⢠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 ⢠Must be legally able to work in Germany
⢠Stimulating work environment ⢠Attractive advancement opportunities ⢠Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request
Apply Nowđ August 21
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đŠđŞ Germany â Remote
đľ âŹ80k - âŹ90k / year
â° Full Time
đĄ Mid-level
đ Senior
đˇââď¸ Project Manager
đŁď¸đŠđŞ German Required
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đˇââď¸ Project Manager
đŤđ¨âđ No degree required
đŁď¸đŠđŞ German Required
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