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Ecocareers · 12 hours ago

Clinical Data Manager II

Atlanta, GA

Full-time

Onsite

Senior Level

6+ years exp

Ecocareers is a confidential company seeking a Clinical Data Manager II. The role involves maintaining and updating EDC user access across multiple clinical studies, managing user access requests, and ensuring compliance with internal SOPs and TMF standards.

Staffing & Recruiting

Responsibilities

Maintain and update EDC user access across multiple clinical studies

Track and manage user access requests in coordination with CRAs and EDC vendors

Curate and maintain standardized tracking spreadsheets for both internal and external use

Transfer verified data from working trackers to production master user lists

Respond to and resolve user-related queries from study teams and EDC builders

Prepare and upload CDM documents to the Trial Master File (TMF) in compliance with internal SOPs and TMF standards

Track document status and ensure completeness and accuracy of TMF content

Collaborate with Sr. CDMs to ensure documents are audit-ready and filed in a timely manner

Assist with study startup, maintenance, and closeout CDM activities as needed

Participate in team meetings, training sessions, and cross-functional collaboration

Support documentation and version control for CDM tools and templates

Maintain clear and organized records of work performed

All other duties as assigned

Qualification

Clinical Data ManagementEDC systemsGCPMicrosoft ExcelTMF structureCommunication skillsOrganizational skillsTeamworkAttention to detail

Required

Bachelor's degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience

6+ years of Clinical Data Management experience in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required

Ability to perform well-defined procedures initially with supervision, and after direction is provided, work independently

Ability to work effectively in a team-oriented environment

Flexibility to adapt to changing project requirements and timelines

Excellent attention to detail and organizational skills

Strong communication and collaboration abilities

Proficiency in Microsoft Excel, Word, and document management tools

Strong organizational skills to manage multiple tasks and projects simultaneously