Job Summary

To manage , review the work of supervisors and a group of technical writers along with providing guidance on writing complex technical documentations.

Key Responsibilities

- 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

Skill Requirements

- Bachelor’s degree/Master’s degree




- 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

Must Have Skill

Clinical Data Management

Good to Have Skill

Other Requirements

ICH GCP and other pertinent regulations

Data Base programming, Edit checks, Data Base Lock, Query Resolutions

Valuable understanding of Clinical Trials

📌 Documentation Manager (India)
🏢 HCLTech
📍 India