04 nov
|
Msd
|
Vicente López
Job Description
The Clinical Research Manager (CRM) is responsible for ensuring the successful execution of assigned clinical studies at the country level, from study start-up through close-out. The CRM coordinates investigators, clinical research sites, vendors, Clinical Research Associates (CRAs), and internal cross-functional teams to ensure studies are delivered in accordance with agreed timelines, quality standards, study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. This role serves as a key connection between local clinical operations and global study teams, proactively managing risks, resolving operational challenges, and driving effective study execution.
Key Responsibilities
• Lead and oversee the operational execution of assigned clinical studies.
• Ensure study activities are delivered in accordance with timelines, quality expectations, protocols, GCP, and applicable local regulatory requirements.
• Coordinate and collaborate with investigators, research sites, CRAs, vendors, and internal study teams.
• Monitor study performance through clinical systems, dashboards, metrics, and data-driven insights.
• Proactively identify operational, regulatory, quality, financial, or timeline risks and implement appropriate mitigation plans.
• Exercise sound judgment and make decisions within the scope of assigned responsibilities, escalating issues when appropriate.
• Support sites and study teams in addressing operational challenges, including patient recruitment, site performance, resource constraints, compliance matters, and stakeholder alignment.
• Build strong relationships across local, regional, and integral teams and effectively influence stakeholders without direct authority.
• Support the adoption of new processes, technologies, digital solutions, and evolving ways of working.
• Contribute to continuous improvement initiatives across Clinical Operations. Required
Qualifications:
• Bachelor's degree in Life Sciences, Health Sciences, or a related field.
• More than 6 years of relevant experience in clinical research.
• Previous experience as a Clinical Research Associate is strongly preferred, ideally including at least 3 years of clinical monitoring experience.
• Oncology Experience is preferred.
• Advanced English proficiency, with the ability to communicate effectively in a global and cross-functional environment.
• Strong knowledge of clinical research operations, Good Clinical Practice (GCP), and applicable local regulations.
• Demonstrated experience working effectively with investigators, clinical research sites, vendors, and cross-functional teams.
• Travel: 20%-30% locally & internationally. The ability to build trusted relationships, influence outcomes, negotiate effectively, and navigate complex stakeholder environments is critical to success in this role. Key Capabilities Accountability & Decision Making
• Takes ownership of outcomes for assigned clinical studies.
• Demonstrates autonomy and sound judgment within the scope of responsibility.
• Effectively determines when issues should be resolved independently and when escalation is required. Digital & Data Proficiency
• Effectively uses clinical systems, dashboards, performance metrics, and data to manage study execution.
• Leverages insights to anticipate risks, identify trends, and support informed decision-making.
• Demonstrates curiosity and openness toward automation, digital solutions, and company-approved AI-enabled tools. Change Management
• Actively contributes to and supports change initiatives.
• Facilitates adoption of new tools, processes, and ways of working.
• Supports colleagues and stakeholders in successfully navigating change. Critical Thinking
• Evaluates complex issues from multiple perspectives.
• Assesses risks, implications, and trade-offs before making decisions.
• Develops pragmatic solutions that balance operational, regulatory, quality, and business considerations. Agile & Flexible Mindset
• Adapts effectively to evolving study priorities and business needs.
• Operates successfully in dynamic, global, cross-functional, and virtual environments.
• Demonstrates resilience and flexibility when managing ambiguity or unexpected challenges. Risk-Based Decision Making & Leadership
• Proactively identifies operational, regulatory, quality, financial, and timeline-related risks.
• Prioritizes actions based on potential impact to the study, patients, sites, and business.
• Applies a structured, risk-based approach to decision-making and problem-solving. Relationship & Stakeholder Management
• Builds strong and trusted relationships with investigators, clinical sites, vendors, and internal stakeholders.
• Influences effectively without relying on formal authority.
• Navigates complex negotiations, competing priorities, and conflict constructively.
• Demonstrates empathy, diplomacy, and strong written and verbal communication skills. Additional location(s) Compensation Information: Required
Skills:
Accountability, Accountability, Adaptability, Change Management, Clinical Data Management, Clinical Research, Clinical Research Management, Clinical Site Management, Clinical Trial Management, Continuous Improvement Techniques, Critical Thinking, Customer Satisfaction Management, Data-Driven Decision Making, Decision Making, Detail-Oriented, Global Change Management, Good Clinical Practice (GCP), Leadership, Operational Activities, Organizational Change Management, Prioritization, Problem Solving, Project Management, Quality Management, Regulatory Submissions {+ 8 more} Preferred
Skills:
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Requirements:
Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 11/11/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
📌 Clinical Research Manager (Vicente López)
🏢 Msd
📍 Vicente López