Director, Data Management & Clinical Data Strategy

Direct Biologics; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Company 401k match up to 4%

Paid Time Off (Vacation & Sick)

Holidays

Stock Option

Job summary

Direct Biologics seeks a Senior Data Manager to lead data management activities in line with ICH/GCP standards. You will design and maintain EDC systems, oversee ESPs, and author key DM documents such as DMPs and Data Review Plans.

You will mentor DM staff, manage regulatory interactions, and implement robust DM SOPs in collaboration with Clinical Operations and QA. A strong background in life sciences and 10+ years in DM is required.

Qualifications

• BA/BS in life sciences or related field.
• 10+ years of relevant industry experience.
• Experience managing department personnel.
• Experience with relevant EDC systems.
• Proficiency in Microsoft Office 365.

Responsibilities

• Execute DM activities and deliverables per ICH/GCP and SOPs.
• Develop/approve DM documents (e.g., DMP, Data Transfer Agreements, Data Review Plans).
• Design and develop Electronic Data Capture (EDC).
• Oversee EDC integrations and maintain CRF library.
• Provide SME input to Protocols, Monitoring Plans, SAPs, CSRs.
• Identify, mitigate, and manage risk in DM issues.
• Develop DM SOPs with Clinical Ops and QA.
• Manage DM external service providers (ESPs).
• Represent DM in regulatory interactions as needed.
• Apply industry best practices to DM systems and processes.
• Lead, train and mentor DM personnel.
• Performs other duties as assigned.

Skills

FDA regulations & GCP

Clinical research process

Cross-functional communication

Issue identification & solutions

Organization & time management

Education

BA/BS in life sciences

Tools

EDC systems

Microsoft Office 365

Job description

Direct Biologics seeks a Senior Data Manager to lead data management activities in line with ICH/GCP standards. You will design and maintain EDC systems, oversee ESPs, and author key DM documents such as DMPs and Data Review Plans.

You will mentor DM staff, manage regulatory interactions, and implement robust DM SOPs in collaboration with Clinical Operations and QA. A strong background in life sciences and 10+ years in DM is required.