Clinical Data Manager
Clinical Data Manager
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Salary Not Disclosed
1 Vacancy
Job Description
- The Data Manager will lead data management (DM) activities for clinical trials including database setup study conduct and closeout.
- The Data Manager will work collaboratively with a crossfunctional team to maintain project timelines and to deliver highquality DM deliverables.
- Lead Data Management activities and ensure study deliverables meet timelines and quality standards.
- Review of Clinical research documents (e.g. Protocols Case Report Forms).
- Create and review electronic Case Report Form (eCRF) specifications.
- Develop critical DM documents such as the Data Management Plan Data Validation Plan eCRF Completion Guidelines Data Entry Guidelines and Data Review Plan.
- Develop edit rules/checks query logic and query messages.
- Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.
- Create and provide training to the clinical team and sites.
- Perform ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.
- Perform database lock/unlock and freeze/unfreeze activities as appropriate for statistical review interim analysis and final database lock.
- Coordinate the archiving of study databases and related documents.
- Create Data Transfer Specifications and perform external vendor reconciliation.
- Perform SAE reconciliation.
- Work to maintain/improve client satisfaction by ensuring high quality service communication and management of clinical data.
- Bachelors degree in clinical/pharmacy/biological/mathematical sciences or related field or nursing.
- Working knowledge of Clinical research and Clinical trial process and related regulatory requirements and terminology.
- Strong knowledge and experience in several Electronic Data Capture systems such as Medidata Rave Oracle Informa OpenClinica and Medrio.
- Perform duties in compliance with SOPs Good Clinical Practices and ICH guidelines.
- Ability to prioritize and to adapt quickly in fastpaced and changing industry conditions.
- Ability to lead a study or data management team independently.
- Proactively drive quality and efficiency to meet timelines and milestones to deliver high quality data management deliverables.
- Excellent verbal and written communication skills.
- Proficient in using Microsoft Office (Outlook Word Excel PowerPoint etc..
Employment Type
Full Time
