Associate Clinical Research Manager, Immunology

🔥 0 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $117k - $184.2k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 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 research protocols in a country or 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 • Ensure compliance 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 on protocols, 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 and quality leadership • Identify and share best practices • Collaborate with outsourcing vendors, investigators, and external partners • Build business relationships with investigators and represent the company • Support local and regional strategy development • Collaborate with headquarters, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs • Travel up to 30% of working time (posting also lists 25% travel requirements)

🎯 Requirements

• Bachelor’s degree in science or comparable field • 4+ years of experience in clinical research • Knowledge of project management and/or site management • Strong organizational skills • Ability to make independent decisions and oversee clinical research activities • Understanding of the local regulatory environment • Scientific and clinical research knowledge • Understanding of clinical trial planning, management, and metrics • Ability to manage multiple deliverables and protocols simultaneously • Ability to link Country Operations and Clinical Trial Teams • Effective written and spoken English and local language proficiency • Project, process, productivity, quality, and delivery management abilities • Strategic thinking and problem-solving skills • Negotiation and conflict-resolution skills • Understanding of cultural differences • Strong diplomatic and empathic skills • No visa sponsorship provided • No relocation provided • 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 • Compassionate and sick days • Remote work arrangement