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 global 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.
Required Skills
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}
Flexible Work Arrangements
Hybrid
