Clinical Data Manager II

Katalyst CRO; Atlanta (GA); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking an experienced Clinical Data Manager to maintain EDC user access across multiple studies, manage access requests, and curate standardized tracking systems. You will support CDM activities, prepare TMF documents, and ensure audit-ready filings in collaboration with Sr.

CDMs and cross-functional teams. The role requires a Bachelor’s degree (Life Sciences/CS) and 6+ years in CDM within biotech/pharma, with strong Excel/Word and document management skills.

Qualifications

• Bachelor's degree or equivalent practical experience in Life Sciences, CS, or related field.
• 6+ years of Clinical Data Management experience in biotech/pharma.
• Ability to perform defined procedures with supervision, then work independently.

Responsibilities

• Maintain and update EDC user access across multiple clinical studies.
• Track and manage user access requests with CRAs and EDC vendors.
• Curate and maintain standardized tracking spreadsheets for internal/external use.
• Transfer verified data from trackers to production master user lists.
• Respond to and resolve user-related queries from study teams and EDC builders.
• Prepare/upload CDM documents to the TMF per SOPs and TMF standards.
• Track document status and ensure TMF content accuracy.
• Collaborate with Sr. CDMs to keep documents audit-ready and timely.
• Assist with study startup, maintenance, and closeout CDM activities.
• Participate in team meetings, training, and cross-functional collaboration.
• Support documentation and version control for CDM tools/templates.
• Maintain clear and organized records of work performed.
• All other duties as assigned.

Skills

Attention to detail

Organizational skills

Communication

Collaboration

Teamwork

Adaptability

Education

Bachelor's degree in Life Sciences/Computer Science or equivalent

Tools

Medidata Rave

Oracle InForm

Microsoft Excel/Word

Document management tools

Job description

• 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

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

Requirements

• 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