The Lead Clinical Data Manager (LCDM) is accountable for clinical data management activities in support of the clinical pipeline for complex studies
Works closely with the Sr. Manager, Clinical Data Management / Analytics in building an efficient and compliant data management function that meets industry standards and supports regulatory inspections
Driving global data management and data analytics strategy related to technologies and processes to increase efficiency, innovation and data quality for complex studies
Leads all data management aspects from startup to database lock, including Data Management Plans (DMP), Edit Checks, and Data Review Plans
Oversees the development and validation of Electronic Data Capture (EDC) systems, ensuring CDISC standards are met.

Bachelor’s degree in a scientific or healthcare-related field or a computer science degree or equivalent professional certification
4 -6 years of experience in clinical data management or a similar role in the medical device or clinical research industry
Strong understanding of clinical trial processes, data management principles and regulatory guidelines
Proficiency in electronic data capture (EDC) systems (i.e. Veeva) 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.

Lead, Clinical Data Manager / Data Analytics

Key skills