Katalyst CRO ยท 1 day ago
Clinical Data Manager II
Atlanta, GA
Contract
Onsite
Senior Level
6+ years expKatalyst CRO is a company specializing in clinical research services, and they are seeking a Clinical Data Manager II to manage user access and maintain data integrity across clinical studies. The role involves collaboration with study teams and ensuring compliance with internal standards while supporting documentation and version control for CDM tools.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
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
Preferred
Experience with EDC systems (e.g., Medidata Rave, Oracle InForm)
Familiarity with TMF structure and regulatory filing practices
Understanding of GCP, GCDMP, and clinical trial workflows
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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