Clinical Studies Specialist II – Clinical Labeling

About the role

K3 Innovations is looking for a detail‑oriented Clinical Studies Specialist II to support a leading global biopharmaceutical organization. The role focuses on clinical labeling operations for investigational product supplies used in clinical trials, ensuring accurate documentation and regulatory compliance.

Key responsibilities

• Create, transfer, and maintain clinical labels for investigational products used in clinical studies.
• Design and generate clinical labels in accordance with established procedures and regulatory requirements.
• Proofread label proofs to ensure accuracy, consistency, and compliance before release.
• Coordinate labeling documentation, approvals, and supporting records throughout the clinical study lifecycle.
• Support additional labeling projects and process improvements as needed.
• Independently manage assigned clinical studies and labeling activities as experience grows.
• Collaborate with global affiliates and internal stakeholders to ensure labeling accuracy and timely execution.
• Maintain professional communication while supporting multiple projects in a highly regulated environment.

Required profile

• High School Diploma or equivalent; Bachelor’s degree in Science, Business, English or a related field preferred.
• Strong attention to detail and commitment to data accuracy.
• Experience with data entry, document review, and quality checking.
• Excellent written and verbal communication skills.
• Ability to work independently while collaborating effectively within a team.
• Comfortable working in a highly regulated environment and following detailed procedures.

Required skills

What we offer

• Opportunity to support global clinical studies at a leading biopharmaceutical company.
• Gain valuable experience in clinical labeling and clinical supply operations.
• Collaborative, quality‑driven environment with international stakeholders.
• Hybrid work schedule offering flexibility while maintaining strong team collaboration.