Senior Project Manager – Dermatology/Rheumatology

Job not on LinkedIn

🔥 0 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 12%

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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 preparing study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports • Participate in planning and conducting the Investigator’s Meeting • Ensure each site has necessary study materials, including investigational products, supplies, special equipment, and safety lab kits • Ensure assigned studies remain audit ready • Monitor study deliverable quality, 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, including 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 identify initiatives needed to meet recruitment timelines • Lead the core project team, including Associate Project Managers, Project Coordinators, and Project Assistants • Ensure team members receive adequate project training • Collaborate with Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs teams to complete deliverables on time and according to applicable standards

🎯 Requirements

• B.Sc. in a related field of study to clinical research • PMP or PRINCE2 certification is an asset • At least 10 years industry experience including a minimum of 3 years in a CRO • At least 7 years of clinical project management experience, including management of all project phases from start-up to closure, all functional services, and vendor management • Experience with mid-size and large studies (>10-15 countries) in multiple regions (NA, SA, APAC, MENA, Europe) • Experience leading multicentered, multinational Phase III clinical trials, including project budget financial tracking and forecasting • Experience in study start-up, regulatory submission, resource management, supervisory experience, CRA, data management, medical writing, or vendor management is an asset • Therapeutic experience managing dermatology, onco-dermatology, rheumatoid arthritis, or oncology trials is an asset • Excellent knowledge of GCP and ICH standards and local country regulations • Excellent knowledge of Microsoft Office suite • Fluency in English with excellent oral and written skills required • Bilingualism (English and local language) is an asset • 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

🏖️ Benefits

• Flexible schedule • Vacation • Home-based position • Ongoing learning and development opportunities • Attractive opportunities for growth and advancement

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