Clinical Data Manager II
Atlanta, GA · On-site
... TMF) in compliance with internal SOPs and TMF standards Track document status and ensure ... Management experience in biotechnology or pharmaceutical industry with excellent understanding of ...
Atlanta, GA · On-site
... TMF) in compliance with internal SOPs and TMF standards Track document status and ensure ... Management experience in biotechnology or pharmaceutical industry with excellent understanding of ...
Atlanta, GA · On-site
... TMF) in compliance with internal SOPs and TMF standards Track document status and ensure ... Management experience in biotechnology or pharmaceutical industry with excellent understanding of ...
... TMF) in compliance with internal SOPs and TMF standards Track document status and ensure ... Management experience in biotechnology or pharmaceutical industry with excellent understanding of ...
... TMF) in compliance with internal SOPs and TMF standards Track document status and ensure ... Management experience in biotechnology or pharmaceutical industry with excellent understanding of ...
Atlanta, GA · On-site
$44K - $57K/yr
... files in TMF, printing and pouching, pre-alerting the destination, invoicing if applicable ... Involvement with air export and import audits. * Assist airfreight manager with daily reports and ...
Atlanta, GA · On-site
$44K - $57K/yr
... files in TMF, printing and pouching, pre-alerting the destination, invoicing if applicable ... Involvement with air export and import audits. * Assist airfreight manager with daily reports and ...
Atlanta, GA · On-site
$44K - $57K/yr
... files in TMF, printing and pouching, pre-alerting the destination, invoicing if applicable ... Involvement with air export and import audits. * Assist airfreight manager with daily reports and ...
Atlanta, GA · On-site
$44K - $57K/yr
... files in TMF, printing and pouching, pre-alerting the destination, invoicing if applicable ... Involvement with air export and import audits. * Assist airfreight manager with daily reports and ...
The CTL at CSSE Senior Manager level is responsible for site-facing engagement and operational ... TMF readiness to the Clinical Operations study team. * Collaborate with Patient Advocacy to ...
The CTL at CSSE Senior Manager level is responsible for site-facing engagement and operational ... TMF readiness to the Clinical Operations study team. * Collaborate with Patient Advocacy to ...
Atlanta, GA · On-site
... e.g., TMF, Clinical Trial Management System (CTMS), etc.). * Strong knowledge of clinical trial processes, ICH-GCP, and regulatory requirements. * Strong knowledge of regulatory start up ...
Atlanta, GA · On-site
... e.g., TMF, Clinical Trial Management System (CTMS), etc.). * Strong knowledge of clinical trial processes, ICH-GCP, and regulatory requirements. * Strong knowledge of regulatory start up ...
$71K - $145K/yr
... TMF) and the Investigator Site File (ISF). A central part of this role involves building and ... The ability to manage multiple tasks, prioritize effectively, and work independently while ...
$71K - $145K/yr
... TMF) and the Investigator Site File (ISF). A central part of this role involves building and ... The ability to manage multiple tasks, prioritize effectively, and work independently while ...
Atlanta, GA · On-site
$23.75 - $31.75/hr
Experience managing complex projects Education * Bachelor's degree Certification Summary ... Oversees the maintenance of sites' regulatory binders for purposes of Trial Master File (TMF ...
Atlanta, GA · On-site
$23.75 - $31.75/hr
Experience managing complex projects Education * Bachelor's degree Certification Summary ... Oversees the maintenance of sites' regulatory binders for purposes of Trial Master File (TMF ...
$24.36 - $29.52
4% of jobs
$29.52 - $34.69
6% of jobs
$34.69 - $39.86
7% of jobs
$43.73 is the 25th percentile. Wages below this are outliers.
$39.86 - $45.02
9% of jobs
$45.02 - $50.19
15% of jobs
The median wage is $52.47 / hr.
$50.19 - $55.36
18% of jobs
$59.04 is the 75th percentile. Wages above this are outliers.
$55.36 - $60.52
21% of jobs
$60.52 - $65.69
7% of jobs
$65.69 - $70.86
6% of jobs
$70.86 - $76.02
3% of jobs
$76.02 - $81.19
2% of jobs
$24
$52
$81
A TMF (Trial Master File) Manager is responsible for overseeing the management, maintenance, and compliance of clinical trial documentation. They ensure that the TMF is accurate, complete, and inspection-ready in accordance with regulatory requirements, such as ICH-GCP and FDA guidelines. TMF Managers collaborate with clinical teams, quality assurance, and regulatory authorities to support audit and inspection activities. Their role is critical in ensuring data integrity and regulatory compliance throughout the clinical trial lifecycle.
To excel as a TMF Manager (Trial Master File Manager), you need a solid understanding of clinical trial documentation, GCP (Good Clinical Practice) guidelines, and regulatory requirements—typically supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems, document management software, and relevant industry certifications such as RAC or DIA TMF certificates is important. Exceptional attention to detail, organizational skills, and the ability to communicate effectively across cross-functional teams distinguish top TMF Managers. These competencies are essential for ensuring the integrity, completeness, and audit-readiness of clinical trial documentation throughout the study lifecycle.
TMF Managers often encounter challenges such as ensuring consistent TMF document quality across multiple studies, meeting tight regulatory submission deadlines, and facilitating communication among global project teams. Keeping the TMF up to date and audit-ready requires strong organizational skills and proactive problem-solving, as studies can involve large volumes of documentation and frequent protocol amendments. Effective TMF Managers routinely collaborate with clinical, regulatory, and quality assurance teams to ensure document accuracy and regulatory compliance. Overcoming these challenges is key to maintaining smooth clinical trial operations and supporting successful regulatory inspections.
The most popular types of Tmf jobs in Georgia are:
For Tmf Manager jobs in Georgia, the most frequently searched job titles are:
The top searched job categories for Tmf Manager jobs in Georgia are:
Cities in Georgia with the most Tmf Manager job openings:

Full-time
Re-posted 23 days ago
Clinical Data Management Specialist
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
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Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.
Scientific research and development services
51 - 200 Employees
South Plainfield, NJ, US