Clinical Operations Manager – Clinical Operations Development

About the role

We are seeking a Clinical Operations Manager for a 2‑year regular (renewable) position within the Clinical Operations Department of the International Vaccine Institute. The role will manage multi‑regional clinical trials of moderate complexity and oversee CRO and vendor activities to ensure compliance with local regulations and ICH‑GCP guidelines.

Key responsibilities

• Provide technical support on study design, protocol development, and preparation of study‑related documents (ICF, IAF, DCs, SOPs, GXP procedures).
• Coordinate CRO on‑site visits, monitor CRO performance, and ensure clinical sites adhere to protocol and regulatory requirements.
• Prepare and submit regulatory documents, manage IRB submissions, and oversee trial master file quality control.
• Manage clinical trial supplies, IP shipment logistics, and communication with manufacturers.
• Lead CAPA coordination, develop monitoring tools, and contribute to SOP/MOP development.

Required profile

• Bachelor’s, Master’s or PhD in health science or related field.
• 9+ years of experience in Clinical Operations, preferably with global CROs, pharmaceutical or biotech companies.
• Demonstrated ability to manage multi‑regional trials and lead project teams.
• Strong client orientation, communication skills, and commitment to continuous learning.

Required skills

• Strong knowledge of ICH‑GCP guidelines.
• Expertise in vaccine clinical research.
• Proficiency with Microsoft PowerPoint, Excel and Word.
• Quality Management and document control experience.