Clinical Research Job at Syngene
Are you ready to lead in the dynamic world of clinical research? Syngene in Bangalore offers an exciting opportunity as a Section Head for those passionate about laboratory excellence and safety. This Clinical Research Job is ideal for professionals with a strong background in clinical laboratory operations and a keen eye for quality standards. As a pivotal part of the team, you’ll ensure compliance with NABL and CAP requirements. Don’t miss this chance to contribute to groundbreaking research and development.
About Syngene:
Syngene is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. The company is committed to providing high-quality services while ensuring a safe working environment for its employees and stakeholders.
Job Details:
- Job Title: Section Head
- Job Location: Translational and clinical research
- Department: Central Laboratory
- Location: Bangalore, KA, IN, 560100
- Division: Discovery Services
Core Purpose of the Role:
Serve as the authorized signatory for lab reports ensuring compliance with NABL and CAP requirements.
Role Accountabilities:
- Authorize and provide expert consultations on the medical significance of clinical laboratory data.
- Interpret, correlate, and communicate laboratory findings to clients, sponsors, investigators, clinical staff, patients, and other stakeholders.
- Ensure compliance with regulatory and accreditation standards while liaising with agencies, administrative officials, and the medical community.
- Oversee implementation of the Quality Management Plan and Quality Policy.
- Implement risk identification and mitigation strategies across all laboratory operations.
- Identify training needs and provide educational programs for medical and laboratory staff.
- Oversee technical and scientific aspects of laboratory operations, including method selection, development, modification, and verification in the Clinical Research Job in Bengaluru.
- Ensure accuracy and proper functioning of test systems; resolve technical issues and implement corrective actions at Syngene Careers.
- Participate in proficiency testing programs and monitor performance.
- Address complaints, requests, and suggestions from staff and users of laboratory services.
- Back up to the lab director for NABL and CAP requirements.
- Primarily responsible for release of reports ensuring TAT compliance.
- Authorized signatory for Central laboratory.
- Participating in advisory services related to scientific matters of CLAB.
Qualification Requirements for the Clinical Research Job:
- Education: MD Biochemistry/ MD Lab medicine/ MD Pathology
- Experience: 02-05 years post MD
- Demonstrated Capability: Worked in a NABL or CAP accredited laboratory.
- Desired Experience: Served as an authorized signatory and Medical Biochemist in an accredited laboratory, managing technical and regulatory requirements in line with ISO 15189:2022.
Skills and Capabilities Required for the Clinical Research Job:
- Proven expertise in clinical laboratory operations, medical biochemistry/pathology, and interpretation of laboratory results.
- Strong understanding of NABL, CAP, ISO 15189:2022, quality systems, regulatory compliance, and audit readiness.
- Ability to authorize reports, ensure scientific accuracy, and support timely report release within defined TAT.
- Competence in method selection, verification, validation, troubleshooting, and technical problem resolution.
- Skilled in risk assessment, proficiency testing, quality indicators, and continual improvement initiatives.
- Effective stakeholder communication with clinicians, sponsors, investigators, clients, regulatory bodies, and internal teams.
- Demonstrated leadership in training, mentoring, team supervision, and building a quality- and safety-focused laboratory culture.
