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

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1886

🏥 Healthcare

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Healthcare • Healthcare Insurance • Pharmaceuticals

Johnson & Johnson is a multinational corporation focused on innovating across multiple sectors of healthcare and medicine. With a commitment to redefining healthcare, the company merges science and technology to address complex diseases through its divisions in innovative medicine and medical technology. Its areas of focus include oncology, immunology, neuroscience, and specialty ophthalmology, as well as interventional solutions and orthopaedics. J&J is dedicated to advancing global health equity and environmental sustainability while fostering innovation, diversity, and inclusion in the workplace. The company strives to provide solutions that connect health and care for providers, patients, and communities worldwide.

📋 Description

• 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

🎯 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; 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

🏖️ 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