Analyst Clinical Data Management
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Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION
Job Title: EDC Database Programmer
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 design develop validate and maintain clinical study databases within EDC systems ensuring data quality protocol compliance and timely study deliverables in alignment with regulatory and organizational standards.
Role Accountabilities
- Design and develop clinical study databases within EDC systems as per protocol and CRF specifications.
- Configure eCRFs visit structures edit checks derivations and study workflows.
- Perform database validation and execute UAT to ensure system functionality and compliance.
- Create and maintain edit check specifications and test scripts.
- Support data cleaning activities by troubleshooting and resolving system-related queries.
- Implement mid-study updates amendments and change control processes.
- Ensure compliance with GCP CDISC standards and 21 CFR Part 11 requirements.
- Maintain study documentation including build documents validation records and audit trails.
- Collaborate with Data Management Biostatistics Clinical Operations and Sponsors for study setup and maintenance.
- Support database lock activities and assist in system integrations (e.g. ePRO IWRS laboratory data).
Leadership Capabilities
- Demonstrates accountability and ownership of assigned studies.
- Proactively communicates risks and challenges to stakeholders.
- Works collaboratively within cross-functional teams.
- Shows willingness to learn and adapt to new systems and processes.
- Contributes positively to team performance and timelines.
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Specific requirements for this role
- Experience
- Hands-on experience in EDC database programming within clinical trials.
- Experience working on Phase IIV studies preferred.
- Exposure to database build testing and maintenance activities.
- Demonstrated Capability
- Ability to interpret study protocols and translate them into database specifications.
- Experience in creating edit checks and validation rules.
- Capability to manage multiple tasks within defined timelines.
- Basic understanding of CDISC standards and regulatory compliance (GCP).
- Education
- Bachelors/masters degree in: Computer Science/Information Technology
- Training in GCP CDISC or clinical data management is an added advantage
Looking for experienced candidates in Clinical Data Management or EDC Programming.
Skills and Capabilities
- Proficiency in EDC platforms (e.g. Medidata Rave Inform Veeva Clinion or equivalent).
- Strong analytical and problem-solving skills.
- Good written and verbal communication skills.
- Attention to detail and commitment to data quality.
- Ability to work in a deadline-driven environment.
Education
- Bachelors/masters degree in: Computer Science/Information Technology
- Training in GCP CDISC or clinical data management is an added advantage
- Certification in Clinical Data Management or EDC systems (preferred).
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.
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Required Experience:
IC
Key Skills
About Company
We are an innovation-led contract research, development and manufacturing organization offering end-to-end solutions to fulfil R&D and manufacturing requirements of our clients
