Training & SOP Compliance Manager – Clinical Research

Location: Bangalore

Department :-Quality Assurance / Clinical Operations

Reporting To : Head – Quality Assurance / Head – Clinical Operations / Facility Director

Employment Type : Full-time About the Organization

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 new recruits and existing employees across clinical research operations.

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.

Position

Summary 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.

The selected candidate will ensure that new 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.

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. Key Responsibilities

1.

New Recruit

Training

Conduct structured induction training for all recent employees.

Train new recruits on organizational policies, clinical research basics, GCP, ethics, SOPs, safety, documentation, and role-specific responsibilities.

Coordinate department-specific training with respective department heads.

Ensure new employees complete required training before independently performing assigned duties.

Maintain individual training files for all new employees.

- SOP Training & Version Control

Train employees on applicable SOPs based on their role and department.

Ensure retraining is conducted whenever SOPs are revised, updated, or newly implemented.

Maintain a training matrix linking each role to applicable SOPs and training requirements.

Track SOP effective dates and ensure timely completion of required training.

Coordinate with QA for SOP issuance, revision, withdrawal, and implementation-related training.

3.

Refresher

Training

Prepare and execute an annual refresher training calendar.

Conduct periodic refresher training on GCP, informed consent, protocol compliance, AE/SAE reporting, source documentation, data integrity, confidentiality, ethics committee requirements, and audit readiness.

Identify areas where repeat training is required based on audit findings, deviations, CAPA, protocol violations, or staff performance gaps.

4.

Training

Documentation

Maintain complete and accurate training records.

Ensure all training attendance sheets, assessment forms, competency checklists,



training certificates, and evaluation forms are filed appropriately.

Maintain individual employee training files.

Ensure all training documentation is audit- and inspection-ready.

Track pending, overdue, and completed training.

5.

Training Needs

Assessment

Identify training needs in consultation with department heads and QA.

Review audit observations, deviations, CAPA trends, protocol violations, and operational errors to identify training gaps.

Develop targeted training sessions based on identified needs.

Recommend additional training for staff where required.

6.

Training Content

Development

Prepare training presentations, handouts, quizzes, case studies, and competency evaluation tools.

Convert SOPs and regulatory requirements into simple, practical training modules.

Update training materials when SOPs, guidelines, or operational practices change.

Develop role-specific training modules for study coordinators, nurses, investigators, laboratory staff, pharmacy staff, recruiters, data entry staff, and administrative teams.

- Compliance & Audit Support

Support internal audits, sponsor audits, ethics committee inspections, and regulatory inspections by providing training documentation.

Ensure training files are complete, updated, and readily retrievable.

Assist QA in demonstrating training compliance during audits.

Track CAPA-related training and ensure documented closure.

- Coordination & Reporting

Prepare monthly training status reports.

Share training compliance dashboards with management.

Follow up with employees and department heads for pending training.

Coordinate training schedules without disrupting clinical study operations.

Maintain confidentiality of employee and study-related information.

Required Qualifications

Essential

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Microbiology, Clinical Research, or a related field.

Certification or formal training in Clinical Research / GCP is preferred.

Strong understanding of ICH-GCP, clinical trial conduct, informed consent, documentation, SOP compliance, and audit requirements.

Prior experience in clinical research, quality assurance, clinical operations, or training.

Preferred

Master’s degree in Life Sciences / Clinical Research / Pharmacy / Healthcare Management.

Experience working in a clinical research site, CRO, hospital research unit, BA/BE center, dermatology research facility, or clinical trial unit.

Prior experience handling training files, SOP training records, audit documentation, and CAPA-related training.

Knowledge of Indian regulatory requirements, ethics committee processes, and sponsor audit expectations.

Experience Required For Coordinator Level





2–4 years of experience in clinical research, documentation, QA, or training coordination.

Required Skills

Strong knowledge of GCP and clinical research processes.

Ability to understand and explain SOPs clearly.

Good presentation and classroom training skills.

Excellent documentation and record-keeping ability.

Strong attention to detail.

Ability to track multiple employees, SOP versions, and training deadlines.

Good communication skills in English and local language.

Ability to prepare PowerPoint presentations, training calendars, trackers, and reports.

Comfortable using MS Excel, Word, PowerPoint, and training trackers.

Audit-readiness mindset.

Ability to work with clinical, QA, medical, technical, and administrative teams.

Key Competencies

Training delivery

SOP interpretation

Documentation control

GCP compliance

Audit preparedness

Communication

Coordination

Follow-up discipline

Attention to detail

Regulatory awareness

People management

Practical problem-solving

Training Areas the Candidate Should Handle The candidate should be able to train staff on topics such as:

Introduction to clinical research

ICH-GCP

Informed consent process

Source documentation

ALCOA+ principles and data integrity

Protocol compliance

Ethics committee requirements

Adverse event and SAE reporting

Subject confidentiality

Study file maintenance

Investigator site file / trial master file basics

SOP training

Role-specific responsibilities

Deviation and CAPA process

Audit and inspection readiness

Equipment handling, where applicable

Safety and emergency procedures

Facility-specific policies

Department-specific workflows

Job Deliverables The selected candidate will be expected to maintain:

Annual training calendar

New employee induction training plan

Role-wise training matrix

SOP-wise training records

Employee-wise training files

Training attendance sheets

Training assessment records

Competency checklists

Training effectiveness evaluation forms

SOP revision training tracker

Refresher training tracker

CAPA-related training tracker

Monthly training compliance report

Audit-ready training documentation

Performance Indicators / KPIs

100% completion of mandatory induction training before independent work allocation.

Timely training on all new and revised SOPs.

No missing training records during audits.

Reduction in repeated SOP-related deviations.

Timely closure of CAPA-related training.

Training compliance percentage by department.

Completion of annual refresher training calendar.

Positive feedback from trainees and department heads.

Improved audit readiness of training files.

Suitable Candidate Backgrounds

Good candidates may come from any of these backgrounds:

Clinical Research Coordinator with strong documentation skills

Clinical Research Associate with site training experience

QA Executive / QA Manager from clinical research or healthcare

GCP Trainer

Clinical Operations Trainer

SOP Documentation Specialist

Nurse Coordinator with clinical trial and training experience

Clinical Research Project Coordinator with compliance exposure

📌 Training & SOP Compliance Manager- Clinical Research (Bengaluru)
🏢 MS CLINICAL RESEARCH
📍 Bengaluru