Company Overview:

A pioneering biopharmaceutical company focused on leveraging structural biology and advanced chemistry to develop innovative therapies for high-impact diseases.

Position Summary:

The Senior Clinical Trial Manager will play a key role in the planning, coordination, and execution of global clinical trials. This position will require strong leadership, organizational, and communication skills to manage internal teams and collaborate with external partners. The Senior Clinical Trial Manager will ensure that clinical trials are conducted on time, within budget, and in compliance with regulatory standards.

Responsibilities:

Trial Planning & Management:

• Develop, oversee, and execute comprehensive trial plans, timelines, and budgets.
• Collaborate with cross-functional teams, including Clinical Operations, Regulatory, Quality Assurance, and Biometrics, to ensure seamless trial planning and execution.
• Lead study start-up activities, including site selection, qualification, and initiation.

Vendor & Site Management:

• Manage vendor relationships, including Contract Research Organizations (CROs), laboratories, and other service providers, ensuring adherence to contract terms and timelines.
• Oversee site monitoring activities, including site visits, audits, and corrective action implementation.
• Provide oversight and guidance to site management teams to ensure timely patient recruitment, retention, and protocol compliance.

Regulatory Compliance:

• Ensure that all clinical trial activities comply with GCP, ICH, and FDA regulations, as well as local regulatory requirements.
• Lead the development and review of essential documents such as protocols, informed consent forms, case report forms, and study reports.

Data Management & Quality Assurance:

• Collaborate with data management teams to ensure accurate and timely data collection and reporting.
• Participate in data review, quality assurance, and validation activities to maintain data integrity.
• Identify, document, and resolve data discrepancies in collaboration with sites and CROs.

Budget & Timeline Tracking:

• Monitor trial budgets, timelines, and milestones, providing regular updates to senior leadership.
• Identify and address potential risks, delays, and budget concerns, implementing mitigation strategies as needed.

Qualifications:

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 5+ years of experience in clinical trial management, with a strong preference for experience in oncology, rare diseases, or immunology.
• Proven track record in managing multi-center, international trials.
• Strong understanding of FDA, EMA, ICH, and GCP guidelines.
• Exceptional organizational, analytical, and problem-solving skills.
• Strong interpersonal and communication skills, with the ability to collaborate effectively across functional teams.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).