Manager, Clinical Operations – Early Development, Oncology

Job not on LinkedIn

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $117k - $201.3k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🏥 Clinical Operations

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This company has sponsored H1B visas in the past.

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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

• Provide line management to direct reports, including goal setting, performance evaluation and talent development • Evaluate and forecast resource needs for the assigned portfolio • Support flexible resourcing, hiring, onboarding and offboarding • Interview, hire, develop and train staff • Ensure training compliance and understanding of relevant processes • Support issue resolution with Ethics Committees, Health Authorities, Investigational Sites and study management teams • Implement organizational changes and communicate priority shifts • Review and approve expenses in compliance with company policies • Provide coaching and mentorship, including accompanied site visits as appropriate • Define and execute long-term ED&CP organizational strategy • Attract, plan, execute and monitor ED&CP clinical trials from feasibility through close-out • Ensure compliance with ICH-GCP, SOPs and procedural documents • Escalate and report fraud, scientific/ethical misconduct and health care compliance breaches • Contribute to CAPA and issue resolution • Build relationships with internal and external stakeholders • Develop country ED&CP capabilities and support study placement • Oversee feasibility and site selection • Lead metrics reviews and follow-up actions • Ensure quality oversight and inspection readiness • Oversee local ED&CP budget and financial reporting • Implement local processes and regulatory requirements • Develop and implement processes and systems to improve study management • Foster continuous improvement, innovation and a Credo-based culture

🎯 Requirements

• Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) • Minimum of 8 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site • ED&CP previous clinical trial experience preferred • Demonstrated AI literacy and an AI enabled mindset, including responsible application of AI tools in daily work • Effective communication and leadership skills • Experience mentoring/coaching others; line management experience desirable • Skilled in leading, hiring, training, developing and evaluating people • Solid decision-making and financial management skills • Effective issue resolution and contingency planning abilities • Excellent knowledge of drug development, clinical research operations and regulatory requirements, including ICH-GCP, HCC and applicable regulations • Ability to synthesize and evaluate data from various reports and sources • Effective communication with internal and external stakeholders • Flexible mindset and ability to work in a fast-changing environment across different therapeutic areas • Ability to operate under limited supervision • Proficient in English language • Computer literacy • Strong interpersonal and negotiating skills • Excellent organizational skills and ability to collaborate and handle multiple priorities within a matrix environment • Ability to perform activities in a timely and accurate manner

🏖️ Benefits

• Consolidated retirement plan (pension) • Savings plan (401(k)) • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; Colorado residents – 48 hours; Washington residents – 56 hours • 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 accommodation support