
201 - 500 Mitarbeiter
💊 Pharmazie
🏥 Gesundheitswesen
💼 Beratung
Pharmaceuticals • Healthcare • Consulting
Als auf Dermatologie spezialisierte CRO (Contract Research Organization) bieten wir wissenschaftliche Expertise, präzise Ergebnisse und höchste Kundenzufriedenheit. Unser einzigartiges Leistungsangebot vereint spezialisierte Contract-Research-Services, fundierte Kenntnisse dermatologischer Prüfzentren in Nordamerika, Reichweite in Europa sowie die erweiterten Kapazitäten eines großen klinischen Forschungszentrums.
🕒 vor 2 Monaten
🗣️🇺🇸🇬🇧 Englisch erforderlich
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201 - 500 Mitarbeiter
💊 Pharmazie
🏥 Gesundheitswesen
💼 Beratung
Pharmaceuticals • Healthcare • Consulting
Als auf Dermatologie spezialisierte CRO (Contract Research Organization) bieten wir wissenschaftliche Expertise, präzise Ergebnisse und höchste Kundenzufriedenheit. Unser einzigartiges Leistungsangebot vereint spezialisierte Contract-Research-Services, fundierte Kenntnisse dermatologischer Prüfzentren in Nordamerika, Reichweite in Europa sowie die erweiterten Kapazitäten eines großen klinischen Forschungszentrums.
• Serve as the 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 the materials needed to perform the study, including investigational products, study supplies, special equipment, and safety lab kits • Ensure assigned studies are audit ready at all times • Monitor the 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, especially internal hours allocated to activities • Identify out-of-scope activities for change orders • Manage trial timelines, budgets, resources, and vendors • Coordinate tasks and deliverables from all 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 and vendors
• At least 7 years of global clinical project management experience, including management of all project phases from start-up to closure, all functional services, and vendor management • At least 10 years of industry experience, including a minimum of 3 years in a CRO • 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 • B.Sc. in a related field of study to clinical research • 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 • 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 • PMP or PRINCE2 certification is an asset • 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 • Bilingualism (English and local language) is an asset
• Attractive advancement opportunities • Stimulating work environment • Accommodations throughout the recruitment and selection process to applicants with disabilities, upon request • Equal opportunity and equitable treatment
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