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Senior Clinical Data Specialist
2 weeks ago
Are you a detail-oriented professional with excellent analytical and project management skills? We are seeking a Clinical Data Manager to join our team.
This role involves defining project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools. You will work closely with cross-functional teams to ensure the accurate and timely delivery of data management services.
The ideal candidate will have a strong understanding of clinical trial methodology, ICH/GCP guidelines, and 21 CFR Part 11. They should also be proficient in EDC and Clinical Data Management Systems, as well as have experience with cloud-based platforms and data reporting tools such as Qlik and Spotfire.
A Bachelor's degree in a health-related field or equivalent experience is preferred. Certification in Clinical Data Management (CCDM) is also desirable. If you have a passion for data analysis and project management, we encourage you to apply for this exciting opportunity.
Key Responsibilities:
- Data Management Services: Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.
- Clinical Trial Methodology: Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.
- Data Analysis and Reporting: Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables. Perform holistic data review and trending analysis via reporting and analytics to proactively identify issues, risks, and develop mitigation strategies.
- Technical Skills: Proficient with EDC and Clinical Data Management Systems, experience with cloud-based platforms, data reporting tools such as Qlik and Spotfire, and knowledge of ICH/GCP guidelines and 21 CFR Part 11.
- Communication and Collaboration: Strong collaborative skills, demonstrated command of the English language with proficiency in both verbal and written communication, and ability to work effectively with cross-functional teams.
Requirements:
- Education: Bachelor's degree in a health-related field or equivalent experience.
- Experience: 5+ years' experience in Clinical Data Management preferred.
- Certification: CCDM Certification preferred.
- Skills: Strong project management experience and project team leadership skills, including work planning, work delegation, and solving complex problems.
