Data Manager (SN0345)
Job Description
We are seeking an experienced Data Manager to oversee our data management processes, ensuring compliance with CDISC standards, regulatory guidelines, and internal Standard Operating Procedures (SOPs).
- The ideal candidate will be responsible for preparing and validating Data Management documents, designing and validating Case Report Forms (CRFs), managing clinical database setups, and overseeing data cleaning and coding activities.
Key Responsibilities
- Ensure adherence to CDISC standards, regulatory guidelines, and internal SOPs in all data management activities.
- Prepare and validate Data Management Plans, Data Validation Documents, and Data Transfer Specifications.
- Design paper Case Report Forms (CRFs) and validate electronic CRFs to ensure accurate data capture.
- Define study specifications for clinical database setup, validate databases, manage database changes, perform data cleaning, and oversee the coding of medications and medical terms.
- Oversee database lock and freeze processes prior to data analysis to ensure data integrity.
- Perform quality control checks and participate in study audits and inspections to maintain high data quality standards.
- Act as the primary liaison with sponsors and external stakeholders on data management activities, ensuring effective communication and collaboration.
- Lead study-specific meetings, provide training to project teams, mentor junior staff, and promote the adoption of digital technologies and innovative tools in data management.
- Track project milestones to ensure timely deliverables and successful project execution.
Qualifications
- Educational Background: Bachelor’s degree in a relevant field.
- Experience: Minimum of 7 years in Clinical Research Organizations (CRO), biotechnology, or pharmaceutical industries, or at least 3 years in a similar data management role.
- Regulatory Knowledge
- Technical Skills
- Software Proficiency
- Communication Skills
- Language Proficiency: Fluent in English
Hiring Team Member
