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Senior Trial Manager, Early Development, Oncology

🕒 October 19

🏖️ New Jersey – Remote

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💵 $92k - $148.3k / year

⏰ Full Time

🟠 Senior

👔 Manager

Where this job comes from

Posted on Johnson & Johnson's careers page, not through a job board

First seen by Remote Rocketship October 19

Still open on Johnson & Johnson's site. Checked 2 hours ago.

Logo of Johnson & Johnson

Johnson & Johnson

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 from start-up through database lock and closeout • Act as the primary country-level contact for assigned studies • Deliver quality data and compliant trial documents and records • Perform Local Trial Manager tasks and potentially Trial Delivery Leader and Site Manager tasks • Collaborate on study feasibility, site assessments, and site selection • Develop country-level study management documents and local trial procedures • Lead local trial teams, recruitment planning, risk management, contingency planning, and budget forecasting • Ensure timely reporting and documentation of SAEs, PQCs, and SUSARs • Maintain trial management systems and analyze trial progress using reports and dashboards • Monitor study progress, initiate corrective and preventive actions, and escalate issues • Support vendor services, vendor selection, invoices, site contracts, and trial budgets • 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 • Coordinate study supplies and clinical drug handling at country or study level • Monitor site recruitment and implement 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 and inspections • Act as protocol expert and represent GCO on cross-functional teams • Establish relationships with investigators, trial coordinators, site staff, and internal stakeholders • Contribute to process improvement, training, and mentoring of Site Managers and Clinical Trial Assistants • Conduct accompanied site visits and take on Champion or Subject Matter Expert initiatives 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 • Demonstrated AI literacy and an AI-enabled mindset, including responsible application of AI tools • 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 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 • Specific therapeutic-area experience/knowledge may be required depending on the position

🏖️ Benefits

• Retirement plan (pension) • 401(k) savings plan • 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 • Fully remote work • Inclusive interview accommodations

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