Clinical Data Manager

Company : Katalyst Healthcares & Life Sciences

Responsibilities:

• The Data Manager will lead 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.
• 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.

Requirements:

• Bachelor's 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 fast-paced 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.).

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