Lead Clinical Data Manager
SKILLS
FULL DESCRIPTION
Lead Clinical Data Manager
[Employer hidden — sign up to reveal] is hiring a Lead Clinical Data Manager to lead data management activities for complex clinical trials. This role is hybrid and full-time.
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 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 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 delivery of high quality and reliable clinical data. The LCDM interacts with senior level management and is critical to the success of complex clinical trials.
- Monitoring progress and following up with team members and line managers
- Implementing and preparing the clinical development strategy
- Gathering input from cross-functional teams
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 collection, validation, processing and analyzing of complex clinical trial data.
- Developing and implementing data management and data analytic procedures.
- Supporting and facilitating review of medical coding.
- Ensuring compliance with applicable regulations, protocols and SOPs.
- Maintaining highest data quality standards throughout data lifecycle.
- Staying updated on industry best practices and regulatory requirements.
- Developing and maintaining data management documentation.
- Designing case report forms (CRFs) and EDC systems.
- Performing cleaning activities including discrepancy management.
- Conducting data validation checks and quality control measures.
- Developing and executing SOPs.
- Collaborating with study team members to resolve data-related issues.
- Generating and reviewing data listings, summaries and reports.
- Serving as primary or backup resource for data management issues.
- Ensuring compliance with GCP, CDISC and other regulations.
- Contributing to development and validation of data management software tools.
- Overseeing data analytics for [Employer hidden — sign up to reveal] clinical trials.
- Collaborating with Clinical Study Managers in leading data analytics.
Qualifications/Education
- Bachelor's degree in a scientific or healthcare-related field or computer science.
- 4-6 years of experience in clinical data management or similar role 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.
- Excellent attention to detail with problem-solving and analytical skills.
- Strong organisational and time management abilities.
Working Conditions
Flexible hybrid working regime. Travel up to 5% of the time may be required.
Application Instructions
Apply via the button. For scams, contact [Employer hidden — sign up to reveal].