Documentation Manager

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

Other Requirements

ICH GCP and other pertinent regulations

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

Good understanding of Clinical Trials