Senior Manager Clinical Trial Lead

Overview

• Drive the operational delivery of clinical trials, ensuring adherence to timelines, budgets, and quality standards.
• Serve as the primary operational contact for cross-functional teams, fostering collaboration and efficiency.
• Lead global or regional trial execution, implementing strategies for participant recruitment and site readiness.
• Collaborate with development leads on protocol creation, amendments, and trial optimization.
• Manage vendor partnerships, ensuring alignment with study objectives and operational strategies.
• Contribute to budget development and maintain financial oversight throughout trial phases.
• Ensure compliance with ICH-GCP, local regulations, and organizational SOPs.
• Provide leadership and mentorship to clinical operations staff, fostering professional growth and teamwork.

Key Responsibilities & Duties

• Plan, execute, and oversee clinical trials from initial synopsis to final reporting.
• Manage site feasibility, selection, initiation, and activation processes effectively.
• Develop and implement participant recruitment strategies in collaboration with stakeholders.
• Direct and oversee CRO and vendor partnerships, ensuring quality and budget compliance.
• Ensure regulatory compliance and address protocol deviations promptly and effectively.
• Coordinate responses to health authorities, ethics committees, and IRBs as required.
• Mentor and manage clinical operations staff, promoting a collaborative and innovative culture.
• Support inspection readiness and contribute to audits and regulatory inspections.
• Maintain decision, action, and risk logs, implementing corrective actions proactively.

Job Requirements

• Bachelor’s degree in Science or related field; advanced degree preferred.
• Minimum of 8 years in global clinical trial management; 10 years preferred.
• Experience in cardiovascular studies or rare diseases is highly desirable.
• Proficiency in ICH-GCP inspections, audits, and regulatory compliance.
• Strong leadership and communication skills to manage cross-functional teams.
• Ability to address operational challenges with innovative and effective solutions.
• Experience in early and late-phase drug development; late-stage experience required.
• Demonstrated ability to mentor and develop clinical operations staff.
• Confidence to challenge norms and drive agile and innovative practices.