Senior Project Manager – Dermatology/Rheumatology

Job not on LinkedIn

🕒 August 21

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 25%

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Logo of Innovaderm Research Inc.

Innovaderm Research Inc.

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.

📋 Description

• Serve as primary contact for the Sponsor • Provide efficient and timely updates on trial progress • Lead client calls effectively • Oversee and actively participate in preparation of study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports • Participate in planning and conducting the Investigator’s Meeting • Ensure sites have necessary investigational products, study supplies, equipment, and safety lab kits • Ensure assigned studies are audit ready at all times • Monitor quality of study deliverables, including vendor and SubCRO deliverables, and address issues • Manage risks and control measures to assure project quality • Analyze discrepancies between planned and actual results • Review and approve responses to quality assurance audits • Control project budgets and internal hours allocated to activities • 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 team members, functional departments, and senior management • Manage and report recruitment status and highlight initiatives needed to meet timelines • Lead the core project team, including Associate Project Managers, Project Coordinators, and Project Assistants • Ensure project team members receive adequate project training • Collaborate with vendors and internal Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs teams

🎯 Requirements

• B.Sc. in a relevant discipline • At least 7 years of industry experience • Minimum 5 years leading multi-center clinical trials (phase II-III) • Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD • Experience managing dermatology trials • Experience managing rheumatology trials an asset • Excellent knowledge of GCP and ICH standards, FDA and local country regulations • Excellent knowledge of Microsoft Office suite • Fluency in English with excellent oral and written skills, required • Ability to work in a team environment and establish good relationships with colleagues and sponsors • Good problem-solving abilities • Strong ability to carry out different projects and work under pressure while meeting timelines • Good knowledge of good clinical practices and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines • Legally authorized to work in Germany

🏖️ Benefits

• Stimulating work environment • Attractive advancement opportunities • Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request

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