Clinical Research Job at Biocon, Bengaluru
Looking for a Clinical Compliance Specialist job in the biopharmaceutical industry with a leading global organization? Biocon Biologics is hiring a Clinical Compliance Specialist for its headquarters in Bengaluru, Karnataka. This Clinical Research Job in Bengaluru is ideal for experienced clinical research professionals who have a strong background in clinical quality, GCP compliance, audits, and quality management systems. If you are passionate about maintaining the highest standards in clinical development and medical affairs, this opportunity at Biocon Careers offers an excellent platform for career growth.
About the Company:
Biocon Biologics is a global biosimilars company and a subsidiary of Biocon Limited, dedicated to improving access to high-quality, affordable biologic medicines worldwide. The company develops and commercializes innovative biologics for patients across multiple therapeutic areas. With a strong focus on research, regulatory excellence, and quality, Biocon Biologics operates in numerous international markets and continues to advance healthcare through scientific innovation and global partnerships.
Job Details:
- Job Title: Clinical Compliance Specialist
- Department: Clinical Development & Medical Affairs
- Location: Bengaluru, Karnataka, India
- Job Type: Full-Time
- Reporting To: Head – Clinical Quality & Compliance
- Industry: Biopharmaceuticals / Clinical Research
- Work Area: Clinical Quality & Compliance
Key Responsibilities of the Clinical Research Job:
- Supports in developing and maintaining ICH-GCP compliant processes to ensure quality in clinical trials conducted.
- Assists activities in the areas of Internal Quality Audits, CAPA (Corrective and Preventive Actions), Quality Management Reviews, and Quality Audits.
- Performs quality review activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines and agency regulations.
- Identifies or assists with identifying non-conformances with requirements.
- Provides suitable recommendations and facilitates ongoing quality improvements while maintaining compliance with applicable study protocols, and standards.
- Supports in conducting vendor audits and works with vendors in eliminating problems via root cause analysis techniques, to ensure that product quality continuously improves.
- Performs internal quality reviews of Trial Master Files.
- Performs internal quality reviews during preparation of study documents e.g. Protocols, IBs, ICFs.
- Performs Sponsor quality visits at Sites as well as CROs (clinical, analytical – PK, immunogenicity etc.) are conducted based on requirements.
- Supports in vendor selection, to evaluate vendors and ensure they have enough capacity and capability to deliver quality products and services on time and in compliance with regulations.
- Performs Risk assessment/analysis of internal systems and processes.
- Supports in GAP analysis (either internally or through external consultant) as and when required for Clinical Development.
- Follows Change control and Change management system as per company procedures.
- Performs other related duties as assigned.
- Performs following activities of Training Department Coordinator, but not limited to, for Clinical Development and Medical Affairs: Create/upload training material/course and questionnaires for the department o Publish assessment questionnaire for the department o Schedules classroom/self-trainings which include CD SOPs/WGDs and Technical trainings in LMS applicable for CD and/or other cross functional teams o Marks attendance for training attendees and Certifying trainings (in case there is no trainer assigned) Review/Generate training reports, CV, JD for self and other users within the department (if required)
- Ensures Master Job Descriptions are available in LMS for all CDMA roles
- Supports in ensuring compliance of Clinical Development & Medical Affairs processes and systems
Qualifications Required for the Clinical Research Job:
- MBBS / MD / Healthcare Degree in alternative Medicine / BDS.
- Around five to six years of experience in Clinical research, preferably in a sponsor organization.
- Strong written and verbal communication skills as well as strong interpersonal skills, with impeccable attention to detail
- Ability to collaborate effectively with internal and external stakeholders as well as cross functional teams
- Must be willing and able to travel for review of systems, processes and data at Sites/ Vendors/CROs as applicable.
