Senior Project Manager, Early Phase and Translational Research

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🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🟠 Senior

👷‍♀️ Projektmanager

👻 Geisterscore 24%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Innovaderm Research Inc.

WebsiteLinkedInAlle Stellen

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.

Beschreibung

• Oversee and manage domestic, regional and/or international clinical research projects • Develop and manage project teams, communications, risk, scope, schedule, cost, quality, and stakeholders • Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials • Act as the main line of communication to stakeholders • Provide input to feasibility, study design, budget development and progress reporting • Mentor and train other project managers and contribute to departmental continuous improvement • Serve as primary contact for sponsors, sites, CRAs, vendors and internal teams • Keep assigned studies audit ready, including training records, central files and system validation • Serve as escalation point for project issues and proactively resolve conflicts • Manage clinical trial timelines, budget, resources, vendors and cross-functional deliverables • Control project budgets, review billed time, and identify out-of-scope activities for change orders • Provide trial progress updates covering site and vendor selection, project plans, budgets, timelines, quality and risk mitigation • Develop and maintain project performance indicators and ensure KPIs remain within contract scope • Define project resource needs and establish succession plans • Lead study start-up, including kick-off meetings, TMF setup, site selection, site activation, vendor setup, contracting and budgeting • Manage risk and control measures to assure project quality • Lead client calls, internal work groups and vendor status meetings; ensure minutes are filed in the TMF • Monitor study deliverable quality and address quality issues • Analyze planned versus actual results and implement corrective actions • Maintain study-specific training matrices and review training records • Review and approve responses to quality assurance audits • Ensure study documents and deliverables are developed on time and meet requirements • Ensure project documentation is filed, maintained and archived in the TMF • Provide status updates in compliance with budgets, scope, timelines, SOPs, GCP, regulatory and study-specific requirements • Manage and report recruitment status and mitigation initiatives • Participate in Investigator’s Meetings • Collaborate with Regulatory Affairs on timely submissions and essential documents • Oversee clinical monitoring activities, including CRA training, monitoring reports, follow-up letters and site issue escalation • Contribute to the Clinical Monitoring Plan • Prepare and conduct CRA training and may perform single-site study initiation visits • Develop annotated site visit reports and monitoring tools • Support CRAs and Lead CRAs as a project contact • Support sites with investigational product, supplies, equipment and safety lab kits • Collaborate with data management on CRF compliance, query resolution and data review through database lock • Prepare and deliver presentations for new business • Provide technical, therapeutic and project management expertise in training and process improvement • Perform other assigned responsibilities when qualified and adequately trained

🎯 Anforderungen

• B.Sc. in a related field of study to clinical research • At least 7 years industry experience • Minimum of 5 years in Phase I-III clinical trial project management with financial accountability • Experience leading concurrent multi-centered, multinational clinical trials with budgets in excess of $25M USD • PMP certification desirable • Experience in cost management, study start up, regulatory submission, resource management, supervisory experience, CRA, data management, medical writing, or vendor management considered an asset • Therapeutic experience managing dermatology 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 • 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 • Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines • Must be legally able to work in the United States

🏖️ Vorteile

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