Site Activation Lead

đź•’ vor 28 Tagen

🇵🇱 Polen – Remote

⏰ Vollzeit

đźź  Senior

đź‘» Geisterscore 14%

infoinfo

🗣️🇺🇸🇬🇧 Englisch erforderlich

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Logo of ICON plc

ICON plc

10.000+ Mitarbeiter

GegrĂĽndet 1990

đź’Ľ Beratung

🏥 Gesundheitswesen

📦 Logistik

Consulting • Healthcare • Logistics

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

• Advance clinical trial start-up activities by understanding client objectives and assisting in country and site distribution planning • Manage day-to-day site start-up and activation activities • Partner with Clinical Operations teams and TAU partners to improve study start-up metrics and implement processes • Provide guidance, oversight, and mentoring to the FSP Site Start Up team • Deliver protocol study start-up, country and site selection, study start-up planning, and modeling activities • Create country-specific ICFs based on the Master ICF • Apply site start-up standards across project portfolios and support continuous improvement • Guide collection and analysis of data affecting study start-up timelines • Use industry tools and data sources to provide start-up timeline and performance data for forecasting • Agree site-level deliverables with the internal team and monitor adherence • Identify potential delays, improve performance, and escalate non-performance • Lead the internal FSP site start-up team and implement the Start Up Project Plan • Drive delivery of client and CRO-supported sites to Ready To Enroll status • Resolve escalated site start-up issues in partnership with the Study Manager

🎯 Anforderungen

• BS degree or international equivalent in a life science • 4 or more years of experience in Clinical Operations, Project Management, study start-up, and trial optimization • Increasing responsibility within a pharmaceutical company, CRO, or relevant industry vendor • At least 2 years of direct responsibility in site activation and managing study start-up processes for clinical research studies at a sponsor or CRO • Experience and knowledge with country-level ICF creation and requirements • Proficiency with software models and database structures • Ability to explain data and facilitate data-driven decision-making processes • Expertise in principles driving country/site start-up and study start-up strategies • Legal right to work in the country where the role is based

🏖️ 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 • Inclusive and accessible workplace • Reasonable accommodations during the recruitment process

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