Clinical Data Manager III

Sigma-Chiconsulting; Hyderabad, Visakhapatnam; Híbrido; INR 1.500.000 - 2.500.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Lead on global studies

Mentoring from senior data managers

Clear career growth paths

Descripción de la vacante

Sigma-Chi Consulting is seeking a Clinical Data Manager III to lead data management activities for studies from start-up to database lock and act as the project contact with minimal supervision.

You will oversee data management plans, CRF design review, data listings, data reconciliation with external data sources, and study progress reporting, ensuring adherence to ICH-GCP and CDISC CDASH across global studies.

Formación

• 5+ years of clinical data management experience
• Degree in Life Sciences, Pharmacy, Nursing or related field
• Hands-on experience with at least one EDC system (Medidata Rave, Veeva or InForm)
• Good understanding of ICH-GCP and CDISC CDASH
• Strong attention to detail and good communication skills

Responsabilidades

• 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 SOPs, ICH-GCP and sponsor requirements

Conocimientos

Attention to detail

Communication skills

Educación

Life Sciences/Pharmacy/Nursing degree

Herramientas

Medidata Rave

Veeva

InForm

Descripción del empleo

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.

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