Senior Trial Manager, Early Development, Oncology

🔥 12 hours ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $92k - $148.3k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare • Pharmaceuticals • Biotechnology

<Johnson & Johnson> is a global healthcare company that researches, develops, manufactures and markets pharmaceuticals, medical devices and consumer health products. The company focuses on innovative medicines and therapies across oncology, immunology, neuroscience and cardiopulmonary areas, and develops MedTech solutions in cardiovascular, orthopaedics, surgery and vision. Johnson & Johnson also engages in health & wellness education, large-scale manufacturing, investor activities and global social-impact initiatives.

📋 Description

• Manage assigned clinical trials locally in one or more countries as the primary country-level contact • Deliver quality data and trial documents compliant with protocols, GCP, healthcare compliance requirements, SOPs, and local regulations • Provide operational oversight from study start-up through database lock and closeout • Perform or support Trial Delivery Leader and Site Manager tasks for Early Development and Clinical Pharmacology studies • Conduct study feasibility and site assessments and recommend suitable sites • Coordinate local trial teams, recruitment planning, risk management, contingency planning, and budget forecasting • Report and document SAEs, PQCs, and SUSARs within required timelines • Maintain trial management systems and analyze trial progress using dashboards and reports • Monitor study progress, initiate corrective and preventive actions, and escalate issues • Support vendor services, vendor selection, invoices, site contracts, and budgets • Set up and conduct investigator meetings and collaborate on site initiation visits • Train and mentor Site Managers and Clinical Trial Assistants • Review visit reports and support analytical risk-based monitoring • Coordinate study supplies and ensure appropriate handling and storage of clinical drug supplies • Monitor site recruitment and develop action plans for non-enrolling sites • Prepare and manage master, country-specific, and site-specific informed consent forms • Organize IEC/HA approvals and ensure regulatory compliance • Support CAPA development and implementation for audits, inspections, and quality visits • Act as protocol expert and primary local GCO contact • Build relationships with investigators, trial coordinators, site staff, and internal stakeholders • Contribute to process improvement initiatives and conduct accompanied site visits • Assume additional champion or subject matter expert responsibilities as assigned

🎯 Requirements

• 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 • Previous clinical trial experience in ED&CP is preferred • Demonstrated AI literacy and an AI-enabled mindset • Ability to apply AI tools responsibly in daily work • 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 • Good written and oral communication skills • Strong IT skills in appropriate software and company systems • Willingness to travel with occasional/regular overnight stays away from home • 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

🏖️ Benefits

• 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