Senior Trial Manager, Early Development, Oncology

🕒 vor 5 Tagen

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $92.000 - $148.350 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

👻 Geisterscore 0%

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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Johnson & Johnson

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1886

🏥 Gesundheitswesen

⚕️ Krankenversicherung

💊 Pharmazie

Healthcare • Healthcare Insurance • Pharmaceuticals

Johnson & Johnson ist ein globales Gesundheitsunternehmen, das Arzneimittel, Therapien und medizinische Geräte in verschiedenen therapeutischen Bereichen entdeckt, entwickelt, herstellt und vermarktet, darunter Onkologie, Neurowissenschaften, Immunologie, Herz-Lungen- und Herz-Kreislauf-Versorgung, Orthopädie, Chirurgie und Augenheilkunde. Das Unternehmen betreibt groß angelegte Forschungs- und Entwicklungsprogramme, klinische Entwicklungs- und Fertigungsprogramme und ist auch aktiv in Mitarbeiterprogrammen, Nachhaltigkeit, globalen Gesundheitsinitiativen und gesellschaftlichem Engagement weltweit.

Beschreibung

• Manage assigned clinical trials locally from start-up through database lock and closeout • Serve as the primary local point of contact for assigned trials • Perform Local Trial Manager tasks and potentially Trial Delivery Leader and Site Manager tasks • Conduct study feasibility and site assessments and recommend suitable sites • Coordinate pre-trial activities and collaborate on final site selection • Develop country-level study management documents, procedures, tools, recruitment plans, risk management, and budget forecasts • Lead local trial teams and coordinate activities in compliance with GCO SOPs, GCP, HCC, regulations, and protocols • Ensure timely reporting and documentation of SAEs, PQCs, and SUSARs • Maintain trial management systems and analyze progress reports and dashboards • Monitor study progress, initiate corrective and preventive actions, and escalate issues • Support vendor services, vendor selection, invoices, site contracts, and budgets • Manage forecasts, finance reporting, and delivery within budget • Set up and conduct Investigator Meetings and collaborate on site initiation visits • Conduct trial team meetings and facilitate Site Manager training • Review Visit Reports and support analytical risk-based monitoring • Support data-entry action plans and monitor site recruitment • Coordinate study supplies and ensure proper handling and storage of clinical drug supplies • Prepare and manage master, country-specific, and site-specific informed consent forms • Organize IEC/HA approvals and ensure local regulatory compliance • Ensure CAPAs are developed and implemented for audits, inspections, and quality visits • Act as protocol expert and develop therapeutic-area and early-development knowledge • Maintain relationships with investigators, site staff, and internal stakeholders • Contribute to process improvement, training, and mentoring of Site Managers and Clinical Trial Assistants • Conduct accompanied site visits and assume champion or subject-matter-expert responsibilities as assigned

🎯 Anforderungen

• A minimum of a BA or BS degree in Life Sciences (or equivalent experience) is required • Minimum of 2 years of clinical trial management experience, in addition to site monitoring experience, is preferred; other relevant experiences and skills may be considered • Previous clinical trial experience in ED&CP is preferred • Demonstrated AI literacy and an AI-enabled mindset, including responsible application of AI tools • Specific therapeutic area experience/knowledge may be required • Solid understanding of the drug development process, including ICH/GCP and local regulatory requirements • Proficient in speaking and writing the country language and English language • Strong IT skills in appropriate software and company systems • Willingness to travel with occasional/regular overnight stays • Ability to work at a fast pace within small exploratory international study teams • Ability to work on multiple trials in parallel in different disease areas

🏖️ Vorteile

• Retirement plan (pension) • Savings plan (401(k)) • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees • Holiday pay, including Floating Holidays – 13 days per calendar year • Work, Personal and Family Time – up to 40 hours per calendar year • Parental Leave – 480 hours within one year of birth/adoption/foster care of a child • Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year • Caregiver Leave – 80 hours in a 52-week rolling period • Volunteer Leave – 32 hours per calendar year • Military Spouse Time-Off – 80 hours per calendar year • Inclusive interview process and disability accommodations