About Sigma-Chi Consulting
With more than a decade of experience, Sigma-Chi Consulting is a trusted biometrics partner to pharmaceutical and biotech sponsors, with teams in Hyderabad and Visakhapatnam supporting clients in the USA and Europe. We deliver biostatistics, statistical programming, clinical data management and AI-driven TLF quality control, with a strong focus on quality and on-time delivery.
Location: Hyderabad / Visakhapatnam, India (hybrid)
Job Overview
As a Clinical Data Manager III you will run data management activities for your studies from start-up to database lock, working as the project point of contact with minimal supervision.
Key Responsibilities
- Prepare core study documents: Data Management Plan, Data Validation Plan and CRF completion guidelines
- Review CRF and eCRF design against the protocol and support database build and UAT
- Review data listings, identify data issues and raise and resolve queries
- Reconcile external data (lab, ECG, IxRS) and serious adverse events
- Track study status and report progress to the sponsor and project team
- Plan work across the data management team and support database close-out and lock
- Work in line with our SOPs, ICH-GCP and sponsor requirements
Requirements
- Degree in Life Sciences, Pharmacy, Nursing or a related field
- 5+ years of clinical data management experience
- Hands-on experience with at least one EDC system (for example Medidata Rave, Veeva or InForm)
- Good understanding of ICH-GCP and CDISC CDASH
- Strong attention to detail and good communication skills
Good to have
- Experience as a lead data manager on global studies
- Basic SAS or SQL skills for listing review
- Medical coding experience (MedDRA, WHODrug)
What we offer
- Lead responsibility on global studies
- Training and mentoring from senior data managers
- A collaborative team with clear career growth paths
How to apply
Use the Quick Apply button on this page, or send your CV to hr@sigma-chiconsulting.com with the job title in the subject line.