Ensure Excellence in Clinical Research: Quality Assurance Specialist
Uphold Data Integrity & Regulatory Compliance in a Global CRO
Lambda Therapeutic Research is a leading global Clinical Research Organization (CRO) dedicated to advancing healthcare through rigorous and reliable clinical research. With our headquarters in Ahmedabad and a strategic international presence, we deliver end-to-end clinical trial services. We are seeking a meticulous Quality Assurance Specialist to safeguard the quality and compliance of our clinical projects, ensuring every deliverable meets the highest standards of accuracy and regulatory adherence.
Key Responsibilities
Comprehensive Clinical Trial Auditing
- Conduct routine audits (in-process, on-site, and off-site) at various trial stages to verify that all activities are performed, recorded, analyzed, and reported in compliance with regulatory, organizational, and client-specific requirements.
- Perform and report system audits according to the annual audit calendar to ensure alignment with Lambda SOPs, quality systems, protocols, and applicable regulations.
Document & Data Review
- Execute retrospective audits of critical study documents, including Informed Consent Forms (ICFs), protocols, project management plans, IMP plans and checklists, Safety Management Plans (SMPs), Clinical Study Reports (CSRs), and medical imaging documentation.
- Audit the clinical database and associated data management documents prior to database lock.
- Calculate and report error rates for the clinical database to the Data Management team and prepare QA status for inclusion in the final Audit Certificate or QA statement.
Quality Systems & Process Oversight
- Assist in the completion of assigned system audits and contribute to the continuous improvement of quality processes.
- Review and help prepare SOPs pertaining to Clinical Data Management (CDM) and Quality Assurance.
- Review key project documents including the Data Management Plan (DMP), Statistical Analysis Plan (SAP), e-CRF/CRF design, TMF, SMF, and site selection visit reports.
System Audits & Reporting
- Conduct system audits of the Clinical Data Management function and prepare detailed audit reports with clear findings and recommendations.
- Ensure all audit observations are accurately documented and followed up to resolution.
Qualifications & Experience
Essential Requirements:
- M.Pharma degree from a recognized institution.
- 2 to 3 years of direct experience in late-phase Quality Assurance within a CRO, pharmaceutical, or biotech company.
- Hands-on experience conducting clinical trial audits (system, process, and document audits).
- Strong knowledge of ICH-GCP guidelines, clinical data management processes, and regulatory compliance requirements.
- Experience in reviewing clinical documents (e.g., protocols, CSRs, TMF) and auditing clinical databases.
- Excellent attention to detail, analytical skills, and written communication abilities for audit reporting.
Preferred Attributes:
- Experience in calculating database error rates and contributing to audit certificates.
- Familiarity with electronic data capture (EDC) systems and clinical trial documentation.
- Proven ability to work cross-functionally with Clinical Operations, Data Management, and Regulatory teams.
- A proactive and quality-focused mindset with strong organizational skills.
Why Join Lambda's Quality Team?
- Guardian of Quality: Play a critical role in ensuring the integrity of clinical data that supports global regulatory submissions and patient safety.
- Professional Growth: Develop deep expertise in GCP auditing and quality systems within a respected global CRO, with a clear career path in QA/QC.
- Systemic Impact: Contribute to the robustness of Lambda’s quality management system and help streamline processes across international projects.
- Collaborative Environment: Work alongside experienced quality and clinical professionals in a supportive, standards-driven culture.
- End-to-End Exposure: Gain insight into the entire clinical trial lifecycle, from study start-up to database lock and reporting.
Ready to uphold the highest standards of quality in global clinical research?
Apply now for the Quality Assurance Specialist position at Lambda.
Lambda Therapeutic Research is an equal opportunity employer. We value precision and integrity and are dedicated to fostering a workplace where quality and compliance thrive through teamwork and expertise.
