Senior Data Manager

HCLTech; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

HCLTech in Hyderabad is seeking a Lead Clinical Data Manager to drive data management across multiple studies, ensuring high quality and compliance. You will define DM plans, create eCRF and edit check specifications, and guide database development through UAT and collaborative reviews.

This role requires strong knowledge of DM processes, regulatory guidelines (GCP, CDISC), and experience with SAS/SQL and Oracle Clinical to deliver accurate, timely study data.

Qualifications

• Lead data management for multiple clinical studies.
• Create and maintain Data Management Plans.
• Develop database specifications including eCRF and edit checks.
• Perform user acceptance testing for databases.
• Collaborate with programmers to build/update databases.
• Lead cross-functional data management and review meetings.
• SAE reconciliation with Safety.
• Represent DM in study team meetings.

Responsibilities

• Lead data management on 4+ clinical studies.
• Oversee DM plans and deliverables.
• Create detailed database specifications and edit checks.
• Perform UAT to ensure correctly built databases.
• Coordinate with programmers to build/update databases.
• Facilitate data review meetings with cross-functional teams.
• Coordinate SAE reconciliation with Safety.
• Represent Data Management in study teams.

Skills

Clinical data management

EDC systems

SAS

SQL

CDISC standards

GCP

Regulatory knowledge

Tools

Oracle Clinical

Job description

• Serve as the lead data manager on 4+ clinical studies
• Manage the creation, execution, and maintenance of Data Management Plans in support of clinical study deliverables
• Create database specifications (including eCRF specifications and edit check specifications) using a fit-for-use mindset
• Responsible for creating and perform user acceptance testing to support database development and ensure correctly built databases
• Collaborate with database programmers to accurately build and update clinical databases
• Lead cross-functional data management and data review meetings
• Perform SAE reconciliation in collaboration with Safety
• Represent Data Management in study team meetings

Required skills and qualifications

• 5+ years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry.
• Strong understanding of clinical trial processes, data management principles and regulatory guidelines.
• Proficiency in electronic data capture (EDC) systems and clinical data management software.
• Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.
• Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Oracle Clinical.
• Excellent attention to detail with problem-solving and analytical skills.
• Strong organisational and time management abilities