SRM Technologies
Website:
srmtech.com
Job details:
Clinical Data Management | SRM Tech
About SRM Tech
SRM Technologies is a global digital and engineering partner delivering capabilities across data and AI, enterprise platforms, embedded and platform engineering, supply chain, and design-to-manufacturing services.
We work across high-impact industries such as Mobility, Life Sciences, Healthcare, and Logistics, supporting enterprises across North America, APAC, and Europe in building intelligent, future-ready ecosystems and driving transformation at scale.
As a Great Place to Work®-certified organization, we are committed to creating an environment where people can learn, grow, and thrive. We believe empowered individuals drive innovation, deliver value to customers, and play a meaningful role in shaping our collective success.
At SRM Tech, every contribution matters, and we are always looking for passionate individuals who are eager to shape their careers with us.
Location: Chennai (Hybrid)
Preferred Experience: 5 - 8 years
About the Role:
We're looking for an experienced Clinical Data Manager to lead end-to-end data management for assigned clinical studies from CRF design and database build through study conduct and lock while serving as the key CDM point of contact for internal and external stakeholder
Key Responsibilities:
- Lead data management planning, CRF design, and database setup
- Act as clinical data point of contact for assigned clinical studies for internal and external stakeholders
- Lead clinical data management aspects of processing radiological images received for client projects in accordance with standard operating procedures
- Lead CDM Tasks & Process in accordance with SOPs’ & Internal QMS Process.
- Author the study documentation of the trial related CDM documents (DMP, eCCG, DTA etc…)
- Lead set-up, conduct and Lock phases of the trial
- Mentors and supports less-experienced team members in building knowledge and developing effective learning capabilities.
- Demonstrates agility in learning new EDC tools and delivering performance on time.
- Follow the internal Quality process for delivering milestones with quality
- Understand the annotations of eCRFs, data linkage between the process and stakeholders, coordinate with all stakeholders.
- Perform Query management, Offline listings review, external reconciliation and other DM tasks as and when required.
- Contribute to RBQM Process , support data analytics team for generation of required standard metrics.
- Review, understand and apply the regulatory standards (CDASH, SDTM ).
- Perform UAT, Validation & Migrations as required.
- Perform other DM Tasks as required
Desired qualification and experience
- Bachelor’s degree or equivalent combination of education and relevant professional experience is required.
- Minimum Five years’ hands-on clinical data management experience in clinical trials is required.
- Experience with database design and implementation, particularly EDC systems and eCRF design, is expected.
- Working knowledge of Good Clinical Practice (GCP) guidelines is required.
- Advanced proficiency with Microsoft Office and preferably some AI knowledge.
SRM Tech is an equal opportunity employer committed to diversity, equity, inclusion, and belonging. We make all hiring decisions based on merit, without bias or discrimination, in line with applicable laws.
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