Clinical Research Manager – Infectious Disease/Vaccine

🔥 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

• Manage end-to-end performance and project management for assigned clinical trial protocols in a country or country cluster • Serve as the main point of contact and link between Country Operations and Clinical Trial Teams • Plan, drive, and track study deliverables, timelines, and results from feasibility and site selection through recruitment, execution, and closeout • Review Monitoring Visit Reports and escalate performance issues and training needs • Perform quality control visits as required • Lead local study teams and train local roles on protocols • Collaborate with and support CRAs as protocol expert • Coordinate activities across local country roles, including CTCs, CRAs, and COMs • Create and execute local risk management plans • Ensure compliance with CTMS, eTMF, and other key systems • Escalate challenges and issues to relevant clinical and operational leadership • Identify and share best practices across trials, countries, and clusters • Collaborate with outsourcing vendors, investigators, and external partners • Serve as country point of contact for programmatically outsourced trials • Build business relationships with investigators and represent the company • Support local and regional strategy development • Collaborate with headquarters, regional and local operations, clinical development, pharmacovigilance, and global medical affairs functions • Travel up to 30% of working time

🎯 Requirements

• 5 years of experience in clinical research • Bachelor's degree in science or comparable field • Knowledge of project management and site management • Strong organizational skills • Ability to make independent decisions and oversee clinical research activities • 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 • Experience linking Country Operations and Clinical Trial Teams • Proficiency in written and spoken English and the local language • Strong written and verbal communication skills • Strategic thinking • Ability to work efficiently in a remote and virtual environment • Understanding of cultural inclusion • Proven strong project management skills and/or project management certification or relevant training program/close mentoring • Strong leadership, conflict resolution, negotiation, diplomatic, empathic, and stakeholder relationship skills • CRA experience preferred • Infectious Disease/Vaccine experience preferred • Trial management experience preferred • No visa sponsorship • Regular employee status

🏖️ 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 • Compassionate days • Sick days • Remote work arrangement