Job Description Training & SOP Compliance Manager – Clinical Research
n Location: Bangalore
n Department :-Quality Assurance / Clinical Operations
n Reporting To : Head – Quality Assurance / Head – Clinical Operations / Facility Director
n Employment Type : Full-time
n About the Organization
n We are a clinical research facility involved in conducting clinical studies in compliance with applicable regulatory, ethical, and quality standards. We are seeking a dedicated Training & SOP Compliance Manager to develop, coordinate, deliver, and document training programs for recent recruits and existing employees across clinical research operations.
n The role is critical to ensuring that all employees are trained on applicable SOPs, protocols, GCP requirements, study procedures, documentation practices, safety reporting, and facility-specific processes before performing assigned responsibilities.
n Position Summary
n The Training & SOP Compliance Manager will be responsible for planning, organizing, delivering, documenting, and monitoring all SOP-related and role-based training activities within the clinical research facility.
n The selected candidate will ensure that current employees receive structured induction training and that existing employees undergo periodic refresher training, SOP revision training, protocol-specific training, and competency-based training as required.
n This position will work closely with Quality Assurance, Clinical Operations, Investigators, Study Coordinators, Laboratory/Technical teams, Data Management, HR, and Administration to ensure that all training records are complete, current, and audit-ready.
n Key Responsibilities
n 1. Recent Recruit Training
n n Conduct structured induction training for all new employees.
n Train new recruits on organizational policies, clinical research basics, GCP, ethics, SOPs, safety, documentation, and role-specific responsibilities.
n Coordinate department-specific training with respective department heads.
n Ensure new employees complete required training before independently performing assigned duties.
n Maintain individual training files for all new employees.
n n 2. SOP Training & Version Control
n n Train employees on applicable SOPs based on their role and department.
n Ensure retraining is conducted whenever SOPs are revised, updated, or newly implemented.
n Maintain a training matrix linking each role to applicable SOPs and training requirements.
n Track SOP effective dates and ensure timely completion of required training.
n Coordinate with QA for SOP issuance, revision, withdrawal, and implementation-related training.
n n 3. Refresher Training
n n Prepare and execute an annual refresher training calendar.
n Conduct periodic refresher training on GCP, informed consent, protocol compliance, AE/SAE reporting, source documentation, data integrity, confidentiality, ethics committee requirements, and audit readiness.
n Identify areas where repeat training is required based on audit findings, deviations, CAPA, protocol violations, or staff performance gaps.
n n 4. Training Documentation
n n Maintain complete and accurate training records.
n Ensure all training attendance sheets, assessment forms, competency checklists, training certificates,



and evaluation forms are filed appropriately.
n Maintain individual employee training files.
n Ensure all training documentation is audit- and inspection-ready.
n Track pending, overdue, and completed training.
n n 5. Training Needs Assessment
n n Identify training needs in consultation with department heads and QA.
n Review audit observations, deviations, CAPA trends, protocol violations, and operational errors to identify training gaps.
n Develop targeted training sessions based on identified needs.
n Recommend additional training for staff where required.
n n 6. Training Content Development
n n Prepare training presentations, handouts, quizzes, case studies, and competency evaluation tools.
n Convert SOPs and regulatory requirements into simple, practical training modules.
n Update training materials when SOPs, guidelines, or operational practices change.
n Develop role-specific training modules for study coordinators, nurses, investigators, laboratory staff, pharmacy staff, recruiters, data entry staff, and administrative teams.
n n 7. Compliance & Audit Support
n n Support internal audits, sponsor audits, ethics committee inspections, and regulatory inspections by providing training documentation.
n Ensure training files are complete, updated, and readily retrievable.
n Assist QA in demonstrating training compliance during audits.
n Track CAPA-related training and ensure documented closure.
n n 8. Coordination & Reporting
n n Prepare monthly training status reports.
n Share training compliance dashboards with management.
n Follow up with employees and department heads for pending training.
n Coordinate training schedules without disrupting clinical study operations.
n Maintain confidentiality of employee and study-related information.
n n Required Qualifications
n Essential
n n Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Microbiology, Clinical Research, or a related field.
n Certification or formal training in Clinical Research / GCP is preferred.
n Strong understanding of ICH-GCP, clinical trial conduct, informed consent, documentation, SOP compliance, and audit requirements.
n Prior experience in clinical research, quality assurance, clinical operations, or training.
n n Preferred
n n Master's degree in Life Sciences / Clinical Research / Pharmacy / Healthcare Management.
n Experience working in a clinical research site, CRO, hospital research unit, BA/BE center, dermatology research facility, or clinical trial unit.
n Prior experience handling training files, SOP training records, audit documentation, and CAPA-related training.
n Knowledge of Indian regulatory requirements, ethics committee processes, and sponsor audit expectations.
n n Experience Required
n For Coordinator Level
n 2–4 years of experience in clinical research, documentation, QA, or training coordination.
n Required Skills




n n Strong knowledge of GCP and clinical research processes.
n Ability to understand and explain SOPs clearly.
n Good presentation and classroom training skills.
n Excellent documentation and record-keeping ability.
n Strong attention to detail.
n Ability to track multiple employees, SOP versions, and training deadlines.
n Positive communication skills in English and local language.
n Ability to prepare PowerPoint presentations, training calendars, trackers, and reports.
n Comfortable using MS Excel, Word, PowerPoint, and training trackers.
n Audit-readiness mindset.
n Ability to work with clinical, QA, medical, technical, and administrative teams.
n n Key Competencies
n n Training delivery
n SOP interpretation
n Documentation control
n GCP compliance
n Audit preparedness
n Communication
n Coordination
n Follow-up discipline
n Attention to detail
n Regulatory awareness
n People management
n Practical problem-solving
n n Training Areas the Candidate Should Handle
n The candidate should be able to train staff on topics such as:
n n Introduction to clinical research
n ICH-GCP
n Informed consent process
n Source documentation
n ALCOA+ principles and data integrity
n Protocol compliance
n Ethics committee requirements
n Adverse event and SAE reporting
n Subject confidentiality
n Study file maintenance
n Investigator site file / trial master file basics
n SOP training
n Role-specific responsibilities
n Deviation and CAPA process
n Audit and inspection readiness
n Equipment handling, where applicable
n Safety and emergency procedures
n Facility-specific policies
n Department-specific workflows
n n Job Deliverables
n The selected candidate will be expected to maintain:
n n Annual training calendar
n New employee induction training plan
n Role-wise training matrix
n SOP-wise training records
n Employee-wise training files
n Training attendance sheets
n Training assessment records
n Competency checklists
n Training effectiveness evaluation forms
n SOP revision training tracker
n Refresher training tracker
n CAPA-related training tracker
n Monthly training compliance report
n Audit-ready training documentation
n n Performance Indicators / KPIs
n n 100% completion of mandatory induction training before independent work allocation.
n Timely training on all new and revised SOPs.
n No missing training records during audits.
n Reduction in repeated SOP-related deviations.
n Timely closure of CAPA-related training.
n Training compliance percentage by department.
n Completion of annual refresher training calendar.
n Positive feedback from trainees and department heads.
n Improved audit readiness of training files.
n n Suitable Candidate Backgrounds
n Good candidates may come from any of these backgrounds:
n n Clinical Research Coordinator with strong documentation skills
n Clinical Research Associate with site training experience
n QA Executive / QA Manager from clinical research or healthcare
n GCP Trainer
n Clinical Operations Trainer
n SOP Documentation Specialist
n Nurse Coordinator with clinical trial and training experience
n Clinical Research Project Coordinator with compliance exposure
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📌 Training & SOP Compliance Manager- Clinical Research (Bengaluru)
🏢 MS CLINICAL RESEARCH
📍 Bengaluru