Job Description

Work Flexibility: Hybrid

What will you do:

• Develop and maintain data management documentation, including study protocols, case report forms and data management plans.
• Design case report forms (CRFs) and electronic data capture (EDC) systems for data collection.
• Perform data entry and cleaning activities, including discrepancy management and query resolution.
• Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
• Conduct data review from other modules and vendors utilized for the study.
• Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing and approval.
• Collaborate with study team members to resolve data-related issues and discrepancies.
• Generate and review data listings, summaries and reports for clinical study reports.
• Serve as a primary or backup resource for issues about data management.
• Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
• Contribute to the development and validation of data management software tools.

What will you need:

Basic qualifications:

• Bachelor’s degree in a scientific or healthcare-related field.
• Minimum 5 years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry. Experience in medical devices company is preferred.
• 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 organizational and time management abilities.

Preferred qualifications:

• Certification in clinical data management (like CCDM).
• Knowledge of CRF design, MS Project and analytical capabilities.
• Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM).
• Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
• Understanding of data privacy and protection regulations (e.g., GDPR).
• Effective communication and interpersonal skills to collaborate with other teams.

Travel Percentage: None