Clinical Data Manager

Syngene International; Bengaluru; Vor Ort; INR 1.200.000 - 2.400.000; Vollzeit

Zusammenfassung

Syngene International is seeking an experienced Clinical Data Manager to independently coordinate data management activities for clinical studies. You will ensure data accuracy, completeness, and GCP/regulatory-compliant deliverables through data review, query management, reconciliation, and database lock support.

The role requires handling CRF/eCRF design, EDc systems, and collaboration with cross-functional teams to drive study timelines and quality.

Qualifikationen

• 5–6 years of experience in Clinical Data Management in CRO/pharma/CRA settings.
• Hands-on end-to-end data management including study startup, cleaning, queries and DB lock.
• Experience with CRF/eCRF design and database validation review.

Aufgaben

• Execute data management activities per study requirements and SOPs.
• Perform data review, validation, cleaning, and discrepancy resolution.
• Raise and manage data queries with sites and internal teams.
• Monitor CRF/eCRF completion and data discrepancies to meet milestones.
• Support database testing, UAT, and data reconciliation tasks as needed.

Kenntnisse

Clinical data management

EDC systems

Data review & validation

Query management

Database lock

Regulatory compliance

Cross-functional collaboration

Documentation & reporting

Ausbildung

Bachelor's or Master's in Life Sciences/Clinical Research

Tools

Clinical databases

Jobbeschreibung

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 independently perform and coordinate clinical data management activities for assigned clinical studies, ensuring accurate, complete, consistent, and GCP/regulatory-compliant clinical trial data. The role is responsible for data review and validation, query management, discrepancy resolution, reconciliation activities, and support for database cleaning and lock activities. Additionally, the role assists in stakeholder communication, ensures adherence to established processes and timelines, and provides guidance to junior team members to support high-quality study deliverables.

Role Accountabilities

• Accountable for executing assigned clinical data management activities in accordance with study requirements, timelines, SOPs, and regulatory guidelines.
• Accountable for performing data review, validation, and cleaning activities to ensure data accuracy, completeness, and consistency.
• Accountable for raising, tracking, and facilitating timely resolution of data queries with investigative sites and internal stakeholders.
• Accountable for monitoring CRF/eCRF completion, query status, and data discrepancies to support study milestones.
• Accountable for supporting CRF/eCRF review, database testing, and User Acceptance Testing (UAT) activities as assigned.
• Accountable for conducting routine data quality checks and escalating data issues, risks, or trends to the Data Manager in a timely manner.
• Accountable for supporting data reconciliation activities, including SAE, laboratory, and other external vendor data reviews as applicable.
• Accountable for maintaining accurate, complete, and inspection-ready study documentation and tracking records.
• Accountable for supporting database lock and study closeout activities through completion of assigned data cleaning tasks.
• Accountable for ensuring compliance with applicable SOPs, ICH-GCP guidelines, protocol requirements, and sponsor expectations.
• Accountable for preparing study metrics, status reports, and data management deliverables as requested.
• Accountable for collaborating effectively with cross-functional teams to support smooth study execution and issue resolution.
• Accountable for sharing knowledge, supporting onboarding activities, and providing guidance to junior team members when required.
• Accountable for identifying opportunities for process improvements and contributing to quality and operational excellence initiatives.
• Accountable for completing assigned tasks within agreed timelines while maintaining high standards of quality and compliance.
• Accountable for performing additional responsibilities assigned by the reporting manager in support of departmental and organizational objectives.

Leadership & Team Support

• Provide guidance, coaching, and training to junior data management team members.
• Support timely delivery of study milestones while ensuring data quality and compliance.
• Contribute to continuous improvement of data management processes and best practices.
• Support audit and inspection readiness activities and ensure adherence to SOPs and quality requirements.
• Assist management with resource planning and workload coordination, as needed.

All employees will consistently demonstrate alignment with our core values

• Integrity
• Professionalism

Specific requirements for this role

Experience

• 5-6 years of experience in Clinical Data Management within CRO, pharmaceutical, biotechnology, or clinical research organizations.
• Experience managing Phase I-IV clinical trials, observational studies, and/or real-world evidence studies.
• Hands-on experience in end-to-end clinical data management activities including study startup, database review, data cleaning, query management, and database lock.
• Experience in CRF/eCRF design, edit check specification development, and database validation review.
• Experience using EDC systems and clinical databases.
• Experience interacting with sponsors and cross-functional study teams.
• Experience supporting audits, inspections, and quality compliance activities.
• Experience mentoring junior team members and coordinating study-level activities.

Skills and Capabilities

• Good understanding of Clinical Data Management processes and clinical trial data lifecycle.
• Strong data review, validation, discrepancy management, and query resolution skills.
• Proficiency in EDC systems and clinical databases.
• Working knowledge of ICH-GCP, regulatory requirements, and data quality standards.
• Familiarity with database lock and reconciliation activities.
• Good analytical, problem-solving, and organizational skills.
• Ability to manage multiple tasks and meet timelines.
• Effective communication and cross-functional collaboration skills.
• Good documentation and reporting skills.
• Demonstrates accountability, attention to detail, 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.
• Certification or training in ICH-GCP, Clinical Data Management, EDC systems, or regulatory compliance is desirable.

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.