About [Employer hidden — sign up to reveal]

[Employer hidden — sign up to reveal] is a global medical products and technologies company, focused on solutions for the management of chronic conditions. With more than 10,000 colleagues, we provide our products and services in around 90 countries. [Employer hidden — sign up to reveal]’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com.

Position Overview

The Lead Clinical Data Manager (LCDM) is accountable for clinical data management activities in support of the clinical pipeline for complex studies. This includes execution and ownership of the CDM operating model, oversight of internal staff, and cross-functional leadership for the delivery of high quality and reliable clinical data.

Key Responsibilities

• Works closely with the Sr. Manager, Clinical Data Management / Analytics in building an efficient and compliant data management function.
• Driving global data management and data analytics strategy related to technologies and processes.
• 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.

Skills & Experience

• Overseeing the collection, validation, processing and analyzing of more complex clinical trial data.
• Developing and implementing data management and data analytic procedures.
• Ensuring compliance with applicable regulations, protocols and SOPs.
• Maintaining highest data quality standards throughout data lifecycle.
• Developing and maintaining data management documentation.
• Designing case report forms (CRFs) and EDC systems.
• Performing cleaning activities including discrepancy management and query resolution.
• Conducting data validation checks and implementing quality control measures.

Qualifications/Education

• Bachelor’s degree in a scientific or healthcare-related field or computer science degree.
• 4-6 years of experience in clinical data management in medical device or clinical research.
• Strong understanding of clinical trial processes and regulatory guidelines.
• Proficiency in EDC systems (i.e. Veeva) and clinical data management software.
• Familiarity with GCP and CDISC standards.
• Knowledge of SAS, SQL and/or Oracle Clinical.

Working Conditions

Remote working

Additional Information

Beware of scams. A formal recruitment process is required. If you receive a suspicious approach, contact [Employer hidden — sign up to reveal].