Project Manager

🕒 vor 16 Tagen

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Vollzeit

🟢 Junior

🟡 Mittelstufe

👷‍♀️ Projektmanager

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ICON plc

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1990

💊 Pharmazie

🧬 Biotechnologie

⚕️ Krankenversicherung

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc ist ein globaler Anbieter klinischer, beratender und kommerzieller Dienstleistungen für verschiedene Bereiche der Gesundheits- und Pharmaindustrie. Das Unternehmen bietet ein breites Spektrum an klinischen Lösungen, darunter dezentralisierte klinische Studien, Lösungen zur kardialen Sicherheit, Frühphasen‑Labore sowie medizinische Bildgebung. Darüber hinaus stellt ICON Technologielösungen bereit, die die Arzneimittelentwicklung von den frühen Phasen bis nach der Markteinführung unterstützen. Die therapeutische Expertise umfasst Kardiologie, Onkologie, Innere Medizin und mehr, mit einem starken Fokus auf transformative Therapien wie Zell‑ und Gentherapien sowie Biosimilars. ICON ist als führende Auftragsforschungsorganisation (CRO) anerkannt, liefert regelmäßig Thought Leadership und trägt zu Branchenpublikationen und ‑veranstaltungen bei. Die Services sind darauf ausgerichtet, klinische Studien zu optimieren, Regulatory Intelligence bereitzustellen und mittels robuster Datenanalysen und patientenzentrierter Lösungen Real‑World Evidence zu generieren.

Beschreibung

• Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval • Ensure compliance with regulatory requirements and company Policies/SOPs • Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs • Populate PTA templates and tools with program-specific information related to investigational product access decisions and implementation • Drive development and finalization of core program documents (e.g. PTA Treatment Guidelines, PTA ICF, agreements and contracts) • Drive decision-making, including selection of appropriate regulatory mechanisms, supply strategy, and safety reporting, in collaboration with cross-functional stakeholders; with support as needed • Ensure alignment across PTA program decisions, documentation, plans, and implementation • Provide forecasting and ensure investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational products • Manage requests for investigational product access through PTA programs, ensuring timely and compliant processing • Manage vendor contracting and deliverables in support of PTA/continued access program execution • Utilize PTA tools, templates, and systems to ensure accurate tracking and reporting of investigational access programs • Monitor quality, KPIs, and program performance; identify issues and escalate as needed • Communicate PTA program status, risks, and updates to stakeholders • Identify risks and implement mitigation strategies specific to investigational product access and program continuity; capture lessons learned and best practices • Ensure inspection readiness, maintain complete and accurate documentation, and perform quality checks for PTA programs • Support other PTA/continued access activities and programs, as assigned

🎯 Anforderungen

• BS/BA (or equivalent experience) • Experience in clinical research or biopharmaceutical operations; including 2+ years leading global, multi-regional PTA programs across the lifecycle, for investigational products prior to regulatory approval; comparable experience leading expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered • General understanding of regulatory frameworks governing pre-approval and continued access to investigational products, ICH GCP, and ethical frameworks of clinical research • Demonstrated ability to manage mild to moderately complex, multi-region PTA programs involving investigational products with a degree of operational and regulatory complexity, with minimal supervision • Proven experience collaborating effectively; influencing stakeholders across functions and levels • Evidence of strong project management skills; including managing competing priorities and solving operational challenges in clinical or investigational program environments • Successful history of working independently in a global environment • Experience with automating processes, process mapping and/or certification in Lean or Six Sigma would be considered an advantage, though it is not a mandatory requirement.

🏖️ Vorteile

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways