Senior Clinical Data Manager jobs in United States
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Vita Global Sciences, a Kelly Company · 18 hours ago

Senior Clinical Data Manager

Vita Global Sciences, a Kelly Company, is seeking a Senior Clinical Data Manager for a remote contract position supporting a global leader in the eye health sector. In this role, you will manage all data management projects within a therapeutic area, ensuring high quality and accurate clinical data while leading a talented team and interacting with various stakeholders.

AnalyticsData VisualizationInformation Technology

Responsibilities

Manage all study specific data management activities such as CRF design, CRF flow definition, DMP preparation, database setup and validation, data entry, data review, discrepancy management, CRF/DCF tracking, data reporting, data coding, database lock, project documentation, transfer to biostatistics for analysis, electronic submission and archiving
Manage external contractors, laboratories and contract research organizations on data management activities
Ensure SOP and guidelines related to data management are followed and maintained
Maintain data management project documentation and overall responsibility for its content
Responsible for sign-off on the final locked database delivered for analysis
Represent Data Management group on the project team meetings and timeline discussions
Support internal as well as vendor audits to ensure compliance with SOP

Qualification

Clinical Data ManagementCRF Design/EDCRegulatory RequirementsProject ManagementOphthalmology Study ExperienceVendor ManagementAnalytical SkillsLeadership SkillsCommunication SkillsInterpersonal SkillsProblem-Solving SkillsOrganizational SkillsDecision-Making Ability

Required

3 years + DM experience
4+ years of industry experience
Bachelors Degree in a related field such as Sciences and/or Health Sciences
Ophthalmology Study experience
Experience in CRF Design/EDC
Ability to facilitate and manage operational activities that have been contracted out to third party vendors (such as CRO's, Labs)
Strong understanding of regulatory requirements and guidelines
Ability to work on a multi-disciplinary team and to contribute across multiple projects with competing priorities
Demonstrated project management skills including pro-active project planning
Demonstrated leadership, decision-making ability, organizational skills and excellent verbal and written communications ability
Strong analytical and problem-solving skills
Broad interpersonal skills to interact with all levels of internal and external customers are necessary

Preferred

EDC experience preferably with Zelta

Company

Vita Global Sciences, a Kelly Company

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From Research To Reality.

Funding

Current Stage
Growth Stage

Leadership Team

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Tim Southwick
President / Founder at Vita Global Sciences
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