Senior Trial Manager, Early Development, Oncology

🕒 October 19

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $92k - $148.3k / year

⏰ Full Time

🟠 Senior

👔 Manager

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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 country-level contact for assigned studies. • Deliver quality data and compliant trial documents and records. • Perform Local Trial Manager tasks and, as applicable, Trial Delivery Leader and Site Manager tasks. • Conduct study feasibility and site assessments and recommend suitable sites. • Develop country-level study management documents, procedures, tools, recruitment plans, risk-management plans, and budget forecasts. • Lead local trial teams and coordinate activities to meet recruitment targets, timelines, quality standards, and budget. • Ensure timely reporting and documentation of SAEs, PQCs, and SUSARs. • Maintain trial management systems and analyze trial progress using reports and dashboards. • Monitor country and overall study progress, initiate corrective and preventive actions, and communicate issues and progress. • Support vendor services, vendor selection, site and vendor invoices, and site contract and budget negotiations. • Manage or collaborate on GCO budget forecasting and financial reporting. • Set up and conduct Investigator Meetings and collaborate on site initiation visits. • Conduct trial team meetings and provide or facilitate Site Manager training. • Review and approve Site Manager visit reports and support analytical risk-based monitoring. • Coordinate study supplies and ensure proper handling, administration, and storage of clinical drug supplies. • Monitor site recruitment and establish action plans for non-enrolling sites. • Prepare and manage master, country-specific, and site-specific informed consent forms. • Organize IEC/HA approvals and ensure compliance with local regulatory requirements. • Ensure CAPAs are developed and implemented for audits, inspections, and quality visits. • Act as an expert for assigned protocols and represent GCO on cross-functional teams when needed. • Establish relationships with investigators, trial coordinators, site staff, and internal stakeholders. • Contribute to process improvement, training, mentoring, and special initiatives. • Conduct accompanied site visits and perform other assigned duties.

🎯 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 Early Development and Clinical Pharmacology (ED&CP) is preferred. • Demonstrated AI literacy and an AI-enabled mindset, including responsible application of AI tools in daily work. • Specific therapeutic-area experience/knowledge may be required. • Solid understanding of the drug development process, including ICH/GCP and local regulatory requirements. • Good leadership skills and solid communication skills. • 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 away from home depending on the region. • Flexible mindset and 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

• Consolidated 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 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 • Inclusive interview-process accommodations for applicants with disabilities

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