Clinical Data Manager

The Data Manager will be responsible for leading data management (DM) activities for clinical trials including database set-up, study conduct and close-out. The Data Manager will work collaboratively with a cross functional team to maintain project timelines and to deliver high quality DM deliverables. Key duties include, but are not limited to:

• Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms (CRFs), Reports and Statistical analysis).
• Develop Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
• Develop CRFs, electronic and/or paper, and database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
• Lead EDC database (DB) specification process and develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
• Reconcile electronic data transfers from vendor to Sponsor.
• Develop test scripts and execution logs for User Acceptance Testing (UAT) and coordinate eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
• 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.
• Perform training on study trial for EDC and create user guides.
• 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.
• 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.
• Coordinate the archiving of study databases and related documents.
• Perform close-out audit for closing of study trial in EDC or other clinical data management DBs.
• Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.
• Assist and provide input into study and project level data analysis plan and Participate in the preparation and presentation of data, when applicable.
• Coordinate and communicate with DB vendors on consistent basis to address Clinical teams requests, project plans, and/or eCRF development activities.

• Bachelor’s degree in a science related field.
• At least 2 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 EDC.