Clinical Research Manager

🔥 0 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $142.4k - $224.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Serve as the main point of contact for assigned protocols and link Country Operations with the clinical trial team • Plan, drive, and track study deliverables, timelines, and results from feasibility and site selection through recruitment, execution, and closeout • Ensure assigned protocols comply with ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting requirements • Review Monitoring Visit Reports and escalate performance issues and training needs • Perform Quality Control visits as required • Lead local study teams, train local roles, support CRAs as protocol expert, and coordinate country activities • Create and execute local risk management plans • Ensure compliance with CTMS, eTMF, and other key systems • Escalate challenges and issues to appropriate clinical research and quality leadership • Collaborate with outsourcing vendors, investigators, and external partners • Serve as country point of contact for programmatically outsourced trials • Support local business needs, including signing contracts and managing budgets when delegated • Collaborate with headquarters, Pharmacovigilance, Regulatory, and Global Medical Affairs functions • Build business relationships with investigators and represent the company in a customer-facing role • Share protocol-specific information and best practices across countries and clusters • Manage end-to-end performance and project management for assigned clinical research protocols

🎯 Requirements

• 5+ years of experience in clinical research • Bachelor’s degree in science or comparable qualification • Knowledge in project management and site management • Strong organizational skills • Ability to make independent decisions and oversee clinical research activities according to global policies • Strong understanding of the local regulatory environment • Strong scientific and clinical research knowledge • Understanding of clinical trial planning, management, and metrics • Ability to manage multiple deliverables and protocols simultaneously • Effective written and spoken English and local language proficiency • Ability to manage resource allocation, processes, productivity, quality, and project delivery • Strategic thinking • Strong leadership skills • Ability to identify problems, conflicts, and opportunities and prepare mitigation plans • Skilled negotiation and conflict resolution • Educational, diplomatic, and empathic skills for maintaining professional relationships • Knowledge of Clinical Quality Management, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, ICH GCP Guidelines, Regulatory Compliance, Risk Management, Strategic Planning, Team Leadership, and Training and Development • No visa sponsorship available • Valid driving license is not required

🏖️ Benefits

• Annual bonus eligibility • Long-term incentive eligibility, if applicable • Medical, dental, and vision healthcare • Other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation days • Compassionate and sick days • Remote work arrangement • 25% travel requirement • No relocation required