Clinical Research Associate Manager

🔥 16 minutes ago

🌐 United States, Puerto Rico – Remote

🇺🇸 United States – Remote 🇵🇷 Puerto Rico – Remote

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $142.4k - $224.1k / year

⏰ Full Time

🟡 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 a team of 6–14 Clinical Research Associates and ensure excellent study and site performance • Ensure strict adherence to local regulations, company SOPs and ICH GCP • Develop talent through training, support and mentoring • Manage low- or non-performance situations and resolve CRA escalations • Work at country level with Clinical Research Managers and other stakeholders to align and develop country capabilities • Collaborate with Partner Line Managers across monitoring functions • Contribute to HQ capacity and resource planning and efficient resource allocation • Allocate work, develop staff and conduct performance appraisals • Support departmental company initiatives and workstreams • Report current manpower and forecast CRA capacity and needs • Ensure consistency of processes and protocol implementation across the country • Interact with sites to resolve site or CRA operational issues in coordination with the study CRM • Attend local Investigator Meetings when requested • Interface with GCTO partners on clinical trial execution • Escalate site performance issues to the Head of Site Management and Monitoring • Liaise with local HR and finance functions • Ensure CRA compliance with corporate policies, procedures and quality standards • Primarily support Vaccine/Infectious Disease trials, with some Cardiovascular therapeutic area work

🎯 Requirements

• Bachelor’s degree in Science • Minimum of 5 years’ experience within Clinical Research • Minimum of 3 years’ experience as CRA monitoring clinical trials • Line management experience preferred or at minimum team leader experience • Ability to work independently and in a team environment • Excellent people management, time management, project management and organizational skills • History of strong performance • Skills and judgment required to be a good steward/decision maker for the company • Fluent in Local Language and business proficient in English, verbal and written • Excellent working knowledge of applicable ICH/GCP regulations and Good Documentation Practices • Expertise in core trial management systems and tools • High emotional intelligence • Strong leadership skills with proven success in people management • Excellent interpersonal and communication skills and conflict management • Ability to build relationships and communicate effectively with external customers, including sites and investigators • Influencing skills • US and Puerto Rico residents only • No visa sponsorship available • 50% travel required

🏖️ Benefits

• Annual bonus and long-term incentive, if applicable • Medical, dental, vision healthcare and other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation • Compassionate and sick days • Remote flexible work arrangement • No relocation required