Clinical Data Manager

Responsibilities:

· Serve as primary contact for DM with all relevant parties both internally (e.g. Project Management, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, external vendors, investigational sites) on a regular basis throughout the study

· Participate in the review of study documents (e.g. protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan)

· Provide support on clinical study database set-up, including eCRF design and database validation requirements

· Develop, review and maintain project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements

· Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks

· Create training materials for EDC users and provide project-specific training as required

· Review and validate clinical data to ensure consistency, accuracy, integrity and completeness

· Create Data Cleaning Plan in consultation with applicable functional groups and oversee data

· releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)

· Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance etc.

· Perform and/or coordinate various data reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data

· Perform Medical Dictionary for Regulatory Activities (MedDRA) and/or World Health

· Organization Drug Dictionary (WHO-DD) medical coding procedures

· Participate in conference calls and/or meetings with vendors and sponsors

· Keep track on project timelines and manage changes of scope, budgets and resourcing needs

· Keep oversight on relevant Data Management activities within a project, as specified in the Data Management Plan

· Manage the database implementation, lock and close-out processes and procedures

· Organize and distribute study data to facilitate statistical analysis and reporting

· Maintain documentation on an ongoing basis and ensure that all filing is up to date

· Plan and create necessary documentation to support internal and external audits; participates in such audits

· Provide leadership, guidance and support to other department members.

Skills:

· Proficiency with various computer applications such as Word, Excel, and PowerPoint required

· Strong written and verbal communication skills including good command of English language

· Representative, outgoing and client focused

· Ability to work in a fast-paced challenging environment of a growing company

· 2 years of Experience required

· Administrative excellence

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