Data Entry Operator - CDM

JOB DESCRIPTION

Job Title: Data Entry Operator 

Job Location: Bangalore

Department: Clinical Data Management – T&CR

About Syngene:  Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’ s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role:

To accurately and efficiently perform clinical data entry, tracking, and quality review activities for assigned studies, ensuring that study data and records are complete, reliable, and maintained in compliance with applicable SOPs, regulatory requirements, and quality standards. The role supports timely study execution through effective management of CRFs, DCFs, electronic documentation, and archival activities while contributing to data integrity and operational excellence.

Role Accountabilities

• Receive, track, and maintain Case Report Forms (CRFs) and Data Clarification Forms (DCFs) received from sponsors, Clinical Research Associates (CRAs), and study teams.
• Perform accurate and timely data entry of clinical study data from CRFs into designated data capture systems and applications.
• Maintain records of CRF and DCF receipt, processing, retrieval, and storage activities.
• Conduct routine data quality reviews to identify discrepancies, missing information, and data entry errors.
• Support query generation and resolution activities by coordinating with relevant stakeholders.
• Perform eCTD-compliant processing of scanned CRFs, including bookmarking, indexing, and Table of Contents creation in accordance with regulatory requirements.
• Prepare and maintain source CRF documents for BA/BE and Phase I studies conducted by Translational & Clinical Research (T&CR).
• Ensure accuracy, completeness, and confidentiality of clinical trial data and documentation.
• Maintain study documentation, logs, and records in compliance with SOPs, GCP guidelines, and regulatory requirements.
• Support document management, filing, archiving, and retrieval activities throughout the study lifecycle.
• Assist in study startup, conduct, and closeout activities related to clinical data handling and documentation.
• Collaborate with data management, clinical operations, and quality teams to support study deliverables.
• Contribute to process improvement initiatives to enhance data quality, efficiency, and compliance.
• Support audits, inspections, and quality assessments by providing required documentation and records.
• Foster a culture of quality, accuracy, accountability, and continuous improvement.
• Perform other duties and responsibilities assigned by the organization from time to time.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Experience

• Fresher or up to 2 years of experience in Clinical Data Management, Clinical Research, Healthcare, Life Sciences, or related fields.
• Basic understanding of clinical research processes, clinical trial documentation, and Good Clinical Practice (GCP) guidelines.
• Familiarity with Clinical Research Forms (CRFs), source documents, and data entry processes is preferred.
• Knowledge of data quality principles, accuracy checks, and documentation practices.
• Basic computer proficiency, including MS Office applications and data entry systems.
• Ability to accurately enter, verify, and maintain clinical study data and records.
• Good attention to detail, organizational skills, and ability to work within defined timelines.
• Strong communication and teamwork skills to collaborate with internal stakeholders and study teams.
• Willingness to learn clinical data management processes, regulatory requirements, and organizational SOPs.
• Internship, academic project, or training experience in clinical research, clinical data management, or related disciplines will be an added advantage.

Skills and Capabilities

• Basic understanding of clinical research and Clinical Data Management processes.
• Knowledge of CRFs, source documents, and data entry procedures.
• Strong attention to detail and accuracy in data entry and review.
• Basic proficiency in MS Office and data capture systems.
• Ability to perform data verification and identify discrepancies.
• Understanding of GCP, data confidentiality, and regulatory compliance requirements.
• Good organizational, documentation, and record management skills.
• Effective communication and teamwork skills.
• Ability to manage multiple tasks and meet timelines.
• Demonstrates accountability, reliability, and a quality-focused mindset.

Education

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, Health Sciences, or a related discipline.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.