Associate Site Manager – Oncology

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🕒 vor 1 Tag

🦌 Connecticut, Maine, +9 weitere Bundesländer – Remote

🦌 Connecticut – Remote 🦞 Maine – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🏈 Ohio – Remote 🍂 Massachusetts – Remote 🚗 Michigan – Remote 🔔 Pennsylvania – Remote ⚓ Rhode Island – Remote 🍁 Vermont – Remote

💵 $76.000 - $121.900 / Jahr

⏰ Vollzeit

🟢 Junior

🟡 Mittelstufe

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Johnson & Johnson

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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

• Serve as the primary contact point between the Sponsor and Investigational Site • Ensure inspection readiness through compliance with protocols, SOPs, GCP, regulations, and guidelines from study start-up through site closure • Assist with site selection, qualification assessment, recruitment and retention planning, initiation, monitoring, and close-out activities • Partner with the Local Trial Manager, Clinical Trial Assistant, and Trial Delivery Leader on site management • Act as the primary local company contact for assigned trial sites • Participate in site feasibility, Site Qualification Visits, and investigator meetings • Execute site initiation, start-up, monitoring, remote monitoring, site management, and close-out activities • Implement analytical risk-based monitoring and resolve monitoring issues • Ensure site staff training and accurate training records • Collaborate with the central study team to activate sites efficiently • Contribute to recruitment strategy and contingency planning • Ensure adequate study supplies and appropriate handling, storage, inventory, and destruction of clinical drug supplies • Ensure timely data entry, query resolution, and accuracy, validity, and completeness of site data • Ensure timely reporting and documentation of adverse events, serious adverse events, and product quality complaints • Maintain trial data and essential documents in relevant systems • Document trial activities, write visit reports and follow-up letters, and communicate status and issues • Review study files and ensure archiving requirements are met • Collaborate on documenting and communicating site/study progress • Participate in team meetings and trainings and provide feedback or leadership as requested • Act as local expert in assigned protocols and develop therapeutic knowledge • Support CAPA completion for audits and site quality issues • Prepare sites for close-out and conduct final close-out visits • Track site-level costs and ensure payments are made when applicable • Maintain relationships with investigators, trial coordinators, site staff, and other stakeholders • Participate in Health Authority and IEC/IRB submissions and notifications as appropriate • Contribute to process improvement and training

🎯 Anforderungen

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or a related scientific discipline • Minimum of 1 year of clinical trial monitoring experience • Basic working knowledge of GCPs, company SOPs, local laws and regulations, assigned protocols, and protocol-specific procedures • Strong computer skills in appropriate software applications and related clinical systems • Strong written and oral communication skills • Willingness to travel up to 60%, including overnight stays away from home • Valid driver’s license issued in one of the 50 United States and a good driving record • Oncology therapeutic area experience preferred • Phase II and Phase III clinical trial experience preferred

🏖️ Vorteile

• Retirement plan (pension) • Savings plan (401(k)) • Eligibility for the Company’s long-term incentive program • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year • 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 the 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