Manager, Clinical Operations

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🔥 10 minutes ago

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Logo of Johnson & Johnson

Johnson & Johnson

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 the operational execution of all phases of clinical trials within assigned therapeutic areas or specific roles • Allocate resources and ensure adherence to timelines, budgets, SOPs, policies, Health Care Compliance, and local regulatory requirements • Support the Country Head in shaping and managing the local organizational structure • Provide line management for Local Trial Managers, Site Managers, Clinical Trial Assistants, and other GCO staff • Oversee staff performance, development, training, project assignments, and workload distribution • Drive innovative solutions, process improvements, and continuous improvement across the local and global GCO organization • Forecast resource needs and deploy the One Delivery Model through vendor collaboration and oversight • Lead talent acquisition, human-resource development, organizational changes, and priority-shift communications • Review and approve expenses in compliance with company policies • Coach and mentor direct reports, including accompanied site visits where appropriate • Define, execute, or support long-term strategy aligned with GCO, GD, and JJIM R&D strategies • Oversee clinical-trial execution and monitoring from feasibility through close-out and ensure inspection readiness • Ensure operational objectives comply with ICH-GCP, SOPs, and other procedural documents • Escalate issues and report breaches appropriately and on time • Maintain relationships with GCO, Local Operating Company, Medical Affairs, internal departments, vendors, health authorities, ethics committees, and investigational sites • Develop country capabilities, oversee feasibility and site selection, and deliver country commitments • Review operational and quality metrics and drive follow-up actions

🎯 Requirements

• Bachelor's degree or equivalent required, preferably in Life Sciences • Minimum of 5 years of clinical research experience in the pharmaceutical industry, CRO, or investigational site • Demonstrated AI literacy and an AI-enabled mindset • Ability to apply AI tools responsibly in daily work • Effective communication and leadership skills • Ability to foster team productivity and cohesiveness • Effective issue resolution and contingency-planning skills • Excellent knowledge of drug development, clinical research operations, ICH-GCP, Health Care Compliance, and applicable regulations • Ability to evaluate data from various reports and sources • Experience mentoring and coaching; line-management experience desirable • Proficiency in decision-making and financial management • Flexible mindset and ability to work in a fast-changing environment • Ability to operate under limited supervision • Proficient in English • Computer literacy • Strong interpersonal and negotiating skills • Excellent organizational skills and ability to collaborate and manage multiple priorities in a matrix environment • Ability to perform activities in a timely and accurate manner

🏖️ Benefits

• Retirement plan (pension) • Savings plan (401(k)) • Long-term incentive program • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; 48 hours per calendar year for employees who reside in Colorado; 56 hours per calendar year for employees who reside in Washington • 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 and reasonable accommodation support

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