Lead Data Manager CDM

JOB DESCRIPTION

Job Title: Lead Data Manager

Job Location: Bangalore

Department: Clinical Data Management

About Syngene: Syngene () 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 companys 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 integrityhealth 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 lead and oversee clinical data management activities across clinical projects ensuring high-quality accurate and compliant clinical trial data. The role is responsible for effective execution of data management processes data quality oversight team leadership stakeholder engagement process improvement and compliance with regulatory and organizational standards.

Role Accountabilities

• Execute and oversee data management activities for assigned clinical studies as Data Manager or Data Reviewer.
• Review and contribute to Data Management Plans (DMPs).
• Perform quality checks on clinical data and identify data discrepancies.
• Raise track and resolve data queries to ensure data accuracy and completeness.
• Track CRFs (Case Report Forms) and query status throughout the study lifecycle.
• Update resolved queries in databases for paper-based studies.
• Ensure the quality integrity consistency and completeness of collected and processed clinical data.
• Provide inputs for proposal development and study feasibility assessments.
• Support CRF design and review.
• Provide inputs for edit check specifications and database validation requirements.
• Generate and communicate periodic project and data management status reports.
• Liaise with sponsors investigators and internal stakeholders to resolve data-related issues.
• Coordinate with relevant departments to facilitate timely query resolution.
• Partner with Quality Assurance (QA) teams during audits and inspections.
• Oversee and support the daily functioning of the EDC Administration team.

Leadership Capabilities

• Lead mentor coach and train data management team members.
• Drive continuous improvement in data management processes and quality standards.
• Ensure timely delivery of project milestones while maintaining compliance and data integrity.
• Monitor team performance and optimize resource utilization.
• Lead audit preparedness activities and ensure adherence to SOPs and quality requirements.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Experience

• Experience in Clinical Data Management within Clinical Research CRO or Pharmaceutical industries.
• Experience managing Phase IIV clinical trials observational studies and/or real-world evidence studies.
• Proven experience in leading end-to-end data management activities including study setup database review data cleaning query management and database lock.
• Experience working with EDC systems clinical databases and data quality review processes.
• Experience in client-facing roles with direct sponsor interactions and project governance participation.
• Demonstrated experience in team leadership and mentoring.
• Experience supporting audits inspections and regulatory compliance activities.
• Experience in SOP development process improvements and departmental quality initiatives.

Skills and Capabilities

• Strong knowledge of Clinical Data Management processes and clinical trial data lifecycle.
• Experience in CRF/eCRF design edit check development and database review.
• Proficiency in query management data cleaning and data quality review.
• Good understanding of EDC systems.
• Knowledge of ICH-GCP CDISC standards and regulatory requirements.
• Ability to prepare and review SOPs and quality-related documentation.
• Strong project planning tracking and risk management skills.
• Experience in managing multiple studies and meeting project client communication and stakeholder management skills.
• Strong written verbal and presentation skills.
• Ability to collaborate effectively with cross-functional teams.
• Proven leadership in mentoring coaching and developing team members.
• Strong problem-solving decision-making and analytical skills.
• Ability to drive operational excellence quality and compliance.
• Demonstrates accountability ownership and a continuous improvement mindset.

Education

• Masters or Bachelors degree in Life Sciences Pharmacy Biotechnology Clinical Research Health Sciences or a related discipline.
• Training or certification in ICH-GCP regulatory compliance and EDC systems 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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.