Senior Manager Clinical Trial Lead

Overview

• Lead operational delivery of cardiovascular clinical trials, ensuring quality, compliance, and efficiency.
• Serve as the primary operational contact for cross-functional study teams.
• Oversee global or regional trial execution, meeting timelines and budget requirements.
• Develop and implement strategies for participant recruitment and site readiness.
• Collaborate with Clinical Development Leads on protocol development and amendments.
• Manage vendor partnerships, ensuring alignment with trial needs and operational strategy.
• Contribute to trial budget development and ongoing financial oversight.
• Ensure compliance with ICH-GCP, local regulations, and company SOPs.
• Provide leadership and mentorship to Clinical Operations staff.

Key Responsibilities & Duties

• Lead planning, execution, and delivery of clinical trials from synopsis through study report.
• Oversee site feasibility, selection, initiation, and activation processes.
• Develop and execute participant recruitment strategies in collaboration with COPL.
• Direct and manage CRO and vendor partnerships, ensuring quality and budget adherence.
• Ensure compliance with regulations and manage protocol deviations effectively.
• Coordinate responses to health authorities, ethics committees, and IRBs.
• Mentor and manage Clinical Operations staff, fostering a collaborative culture.
• Contribute to inspection readiness and support audits and regulatory inspections.
• Maintain decision, action, and risk logs, implementing corrective actions as needed.

Job Requirements

• Bachelor’s degree in Science; advanced degree preferred.
• Minimum 8 years of experience in global clinical trial management; 10 years preferred.
• Experience in cardiovascular studies and/or rare diseases is desirable.
• Proficiency in ICH-GCP inspections, audits, and inspection preparedness.
• Strong communication skills and ability to lead cross-functional teams.
• Capability to devise plans for operational challenges like site activation and data cleaning.
• Experience in early and late-phase drug development; late-stage development experience required.
• Confidence to challenge status quo and work with agility and innovation.
• Demonstrated ability to mentor and develop Clinical Operations staff.