Clinical Qa Compliance Specialist

Summary: The Clinical Quality Assurance/Compliance Specialist will play a crucial role in ensuring compliance with regulations, guidelines, and study conduct within clinical trials. This individual will provide ongoing compliance support to studies, review study-specific documents and trainings, conduct compliance checks and inspections, manage risks and issues, and support audits, inspections, and deviation/CAPA processes. The ideal candidate will have 3 to 5 years of solid experience in clinical quality assurance or trial monitoring, with extensive experience in a global biopharma environment and a strong focus on strategic development, process management, leadership, and communication.

Responsibilities:

1. Ongoing Compliance Support:

   • Respond to questions related to procedures, regulations, guidelines, and study conduct throughout the duration of the study.
   • Provide continuous support to ensure ongoing compliance with regulatory requirements.

2. Review of Study-Specific Documents and Trainings:

   • Conduct ongoing reviews of study-specific documents and trainings to ensure compliance with regulations and guidelines.
   • Ensure consistency and accuracy in study-related materials throughout the duration of the study.

3. Compliance Checks and Inspections:

   • Conduct inspection readiness checks and assessments on specific processes and activities related to clinical trials.
   • Independently evaluate compliance with regulations and guidelines, acting as a separate, standalone resource.

4. Risk and Issue Management Support:

   • Identify, assess, and manage risks and issues related to study conduct and compliance.
   • Provide ongoing support to address and mitigate risks throughout the duration of the study.

5. Audit, Inspection, and Deviation/CAPA Support:

   • Support audit, inspection, and deviation/CAPA processes independently from study assignments.
   • Assist in preparing for and responding to Health Authority audits and inspections, ensuring timely resolution of findings.

Qualifications:

• 3-5 years of experience in clinical quality assurance or trial monitoring, preferably in a global biopharma environment.
• Strong understanding of regulatory requirements and guidelines related to clinical trials.
• Experience in managing processes with a continuous improvement approach.
• Excellent leadership, communication, collaboration, influencing, and negotiation skills.
• Ability to navigate and negotiate competing priorities in a challenging environment.
• Previous experience supporting teams during Health Authority audits and inspections.
• Proficiency in English language, both written and verbal.
• Strong planning, coordination, organizational, and time management skills.
• Ability to work independently and as a team member, with attention to detail and strategic thinking abilities.