Senior Data Manager- Remote

About ClinChoice

ClinChoice is a global CRO dedicated to offering high-quality full development service to biopharmaceutical, medical device, and consumer products clients. Our services include clinical operations, project management, biostatistics, statistical Programming, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major offices across US, China, Europe, India, Japan, and the Philippines with over 2,400 employees globally.

Job Responsibilities

• Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
• Lead AE/SAE data reconciliation in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.
• Develop Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
• Coordinate the archiving of study databases and related documents.
• Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
• Participate in the preparation and presentation of data, when applicable.
• Assist and provide input into study and project level data analysis plan.
• Create and maintain all UAT documents, included but not limited to: edit check document, issue logs, UAT summary report.
• Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
• Perform other activities as required.
• Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
• Lead EDC database (DB) specification process.
• Participate in the review of Clinical research documents (e.g., Protocols, Case Report Forms, Reports and Statistical analysis).
• Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, and query logic and data validations.
• Maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.
• Coordinate and communicate with DB vendors on consistent basis to address Clinical team’s requests, project plans, and/or eCRF development activities.
• Develop test scripts and execution logs for User Acceptance Testing (UAT).
• Lead and Perform UAT of database and edit checks.
• Reconcile electronic data transfers from vendor to Sponsor.
• Develop Case Report Form (CRF), electronic and/or paper.
• Perform training on study trial for EDC and create user guides.

Qualifications

• Bachelor’s degree in a science related field.
• At least 6 years data management and/or related work experience in a medical device or pharmaceutical industry/company is preferred.
• Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Working knowledge of Clinical database applications such as Electronic Data Capture (EDC)

ClinChoice is an Equal Opportunity Employer / Committed to Diversity