Senior Clinical Research Manager

📋 Description

• • Oversee clinical monitoring activities and lead a team of Clinical Research Associates (CRAs) to ensure full compliance with ICH-GCP, local regulations, and company SOPs across all clinical trials.
• • Allocate CRA resources strategically based on workload assessments to maintain high-quality monitoring and meet study deliverables on time.
• • Ensure CRAs possess the required monitoring knowledge and skills to execute trial activities effectively and maintain compliance standards.
• • Manage and address CRA performance and quality indicators, implementing corrective actions where necessary to uphold regulatory and operational integrity.
• • Strengthen relationships with clinical trial sites to enhance performance, improve data quality, and protect the company’s reputation for trial delivery.
• • Review monitoring quality data, identify gaps or non-compliance issues, and implement resolution strategies aligned with ICH-GCP and health authority requirements.
• • Conduct assessment visits and accompanied monitoring visits to evaluate CRA competency, detect deviations, and guide improvement efforts.
• • Support the execution of site audits, inspections, and Site Compliance Visits (SCVs), ensuring timely corrective actions and follow-up on identified findings.
• • Review and approve expenses related to CRA activities, ensuring adherence to company policies and local financial best practices while identifying cost-saving opportunities without compromising quality.
• • Lead strategic initiatives and task forces aimed at optimizing clinical operations processes, driving projects from planning through completion in collaboration with cross-functional teams.
• • Recruit, onboard, and integrate new team members to align with team culture and operational objectives.
• • Assign tasks based on individual strengths and team goals to maximize productivity and developmental growth.
• • Provide ongoing support and resources to enable team members to perform their roles effectively.
• • Foster open communication and collaboration within the team and across departments, serving as the primary point of contact for issue escalation and feedback.
• • Conduct regular performance evaluations and deliver constructive feedback to promote continuous improvement and accountability.
• • Mentor junior Clinical Research Managers (CRMs), offering guidance, professional development insights, and feedback to enhance team capability and consistency.
• • Support team members in identifying and pursuing professional development opportunities to advance their careers.
• • Address personnel issues promptly and fairly to maintain a positive, inclusive, and high-performing work environment.
• • Maintain proficiency in Microsoft Word, Excel, PowerPoint, and Outlook for daily operational and reporting tasks.
• • Demonstrate fluency in written and verbal English to ensure clear communication across global teams and regulatory documentation.
• • Travel as required to support clinical trial monitoring, site visits, and operational needs; must hold a valid driver’s license in applicable countries.
• • Apply deep understanding of the drug development process, including expertise in international standards (ICH GCP) and health authority expectations.
• • Leverage prior experience as a Clinical Research Associate (CRA) to inform leadership decisions and team development strategies.
• • Bring demonstrated leadership experience in clinical research within biotech, pharmaceutical, or CRO environments, with a preference for oncology trial experience.
• • Exhibit the company’s global competencies including Fosters Teamwork, Provides and Solicits Honest Feedback, Continuous Learning, Results-Oriented, and Communicates with Clarity.