Position Summary:

The CRO/CRA Executive will play a critical role in the execution of clinical trials within a cGMP-compliant cell therapy and advanced biologics pipeline. This position is responsible for end-to-end clinical trial coordination, ensuring alignment with regulatory standards, product quality requirements, and translational research objectives. The role supports Phase I/II clinical programs and works closely with manufacturing, regulatory, and medical teams to bridge clinical and production workflows.

Key Responsibilities:

• Oversee and execute clinical trial activities for cell therapy and biologics programs in compliance with cGMP, ICH-GCP, and regulatory requirements.
• Coordinate clinical site selection, initiation, monitoring, and close-out activities.
• Act as a key interface between clinical operations and cGMP manufacturing teams to ensure product integrity and chain-of-custody compliance.
• Ensure proper handling, storage, and documentation of investigational products, including cell-based therapies.
• Manage trial master file (TMF), regulatory documentation, and submission readiness.
• Support IND/CTA submissions and regulatory interactions.
• Monitor patient safety, adverse events, and protocol adherence.
• Ensure audit and inspection readiness across clinical and manufacturing interfaces.
• Identify operational risks and implement mitigation strategies across the clinical pipeline.

Qualifications & Requirements:

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Pharmacy, or related field.
• Strong understanding of cGMP environments and clinical trial integration.
• Working knowledge of ICH-GCP, FDA, EMA, or relevant regulatory frameworks.
• Experience supporting early-phase (Phase I/II) clinical trials is preferred.
• Strong project management and cross-functional coordination skills.

Key Competencies:

• Strong understanding of translational medicine and clinical-manufacturing integration
• Attention to detail and compliance-driven mindset
• Stakeholder management across scientific, clinical, and operational teams
• Problem-solving in complex, regulated environments
• Ability to operate in high-growth, fast-paced biotech settings

Reporting Line:

This role reports to the Lab Director, with dotted-line alignment to cGMP Manufacturing or Technical Operations.

Strategic Impact:

This role is critical in advancing the company’s cell therapy pipeline from clinical development to commercialization, ensuring seamless integration between cGMP manufacturing capabilities and clinical execution.