Director, Data Management

Direct Biologics

. Successful and timely execution of DM activities and deliverables in compliance with International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and Standard Operating Procedures (SOPs) .

Posted 9/23/2026full-timeRemote • Texas • United StatesLead💰 $165,000 - $175,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Data Management (DM) activities, ensuring compliance with ICH and GCP guidelines while effectively managing external service providers and leading DM personnel. Proficient in developing and approving DM documents and implementing industry best practices in clinical research.

Highest-signal resume keywords

FDA RegulationsICH-GCP GuidelinesElectronic Data Capture (EDC)Data Management PlansClinical Research Process

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data ManagementData Transfer AgreementsCase Report Form DevelopmentRisk ManagementStandard Operating Procedures (SOPs)Statistical Analysis PlansClinical Study ReportsData Review PlansEDC System ManagementClinical Trial Documentation

Soft Skills

Interpersonal SkillsCross-Functional CommunicationOrganizational SkillsTime ManagementProblem-Solving

Tools & Technologies

Microsoft Office 365EDC Systems

Industry Keywords

Good Clinical Practice (GCP)International Council for Harmonisation (ICH)Clinical OperationsQuality AssuranceExternal Service Providers (ESPs)

About the role

Key responsibilities & impact

Successful and timely execution of DM activities and deliverables in compliance with International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and Standard Operating Procedures (SOPs)
Develops and/or approves DM documents, including Data Management Plans, Data Transfer Agreements, and Data Review Plans
Designs and develops Electronic Data Capture (EDC)
Oversees and coordinates EDC integrations
Develops and maintains standard Case Report Form library
Provides subject matter expertise to the development of trial documents, including Protocols, Monitoring Plans, Statistical Analysis Plans, and Clinical Study Reports
Proactively identifies, mitigates, and manages risk in data management issues
Develops and implements DM SOPs in partnership with Clinical Operations and Quality Assurance
Manages DM external service providers (ESPs)
Represents DM in interactions with regulatory authorities, as needed
Applies current industry best practices to DM systems and processes
Leads, trains and mentors DM personnel
Performs other duties as assigned

Requirements

What you’ll need

Strong knowledge of FDA regulations and ICH-GCP guidelines
Thorough knowledge of the clinical research process
Strong interpersonal skills with the ability to effectively communicate cross-functionally at all levels of the organization, as well as externally with stakeholders and ESPs
Ability to identify issues and independently assess and recommend specific solutions
Strong organizational skills, prioritization, time management, and cross functional collaboration
BA/BS in life sciences relevant field, preferable
10+ years of relevant industry experience
Experience managing department personnel
Experience with relevant EDC systems
Proficiency in Microsoft Office 365

Benefits

Comp & perks

Health Care Plan (Medical, Dental & Vision)
Company 401k match up to 4%
Paid Time Off (Vacation & Sick)
Holidays
Stock Option