We are seeking a candidate at our headquarters in Bangalore, India to support our clinical quality and compliance function within the Clinical Development and Medical Affairs organization. Reporting to the Head Clinical Quality and Compliance, Clinical Quality and Compliance Specialist will support in continuous improvement of processes and methods established to ensure the quality of studies conducted by Clinical Development and Medical Affairs.
Responsibilities
- 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: o 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
- Bachelors or Master's degree, equivalent or higher qualification within Lifesciences/ Pharmacy/ MBBS / MD / Healthcare Degree in alternative Medicine / BDS.
- Around five to six years of experience in Clinical research, preferably in a sponsor organization.
- Solid 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.