Director, Data Management & Compliance - Stock Options

Direct Biologics; Austin (TX); Vor Ort; USD 120.000 - 170.000; Vollzeit

Benefits dieser Stelle

Health Care Plan (Medical, Dental & 3)

Company 401k match up to 4%

Paid Time Off

Holidays

Stock Option

Zusammenfassung

Direct Biologics is seeking a senior Scientist to lead Data Management activities in support of clinical trials. You will design and implement EDC systems, develop DM documents, and ensure compliance with ICH/GCP and SOPs.

The role requires 10+ years in clinical data management, strong leadership, and cross-functional collaboration. Candidates should have a BA/BS in life sciences and proficiency with EDC and MS Office 365.

Qualifikationen

• BA/BS in life sciences or related field and strong knowledge of FDA regulations and ICH-GCP guidelines.
• 10+ years of relevant industry experience in data management or clinical research.
• Experience managing department personnel and cross-functional teams.
• Experience with Data Management Systems (EDC) and data standards.
• Proficiency with Microsoft Office 365 and related productivity tools.

Aufgaben

• Execute DM activities and deliverables in compliance with ICH/GCP and SOPs.
• Develop/approve Data Management documents (Data Management Plan, Data Transfer Agreements, Data Review Plans).
• Design and develop Electronic Data Capture (EDC) systems; oversee EDC integrations.
• Maintain standard Case Report Form libraries and DM SOPs in partnership with Clinical Ops and QA.
• Provide SME input to Protocols, Monitoring Plans, SAPs, CSRs, etc.
• Identify, mitigate, and manage data management risks.
• Manage external data management service providers (ESPs).
• Represent DM in interactions with regulatory authorities as needed.
• Mentor and train DM personnel; lead DM projects.
• Perform other duties as assigned.

Kenntnisse

FDA regulations

ICH-GCP guidelines

Clinical research process

Cross-functional communication

Issue identification & solutioning

Organization & time management

Ausbildung

BA/BS in life sciences

Tools

EDC systems

Microsoft Office 365

Jobbeschreibung

Direct Biologics is seeking a senior Scientist to lead Data Management activities in support of clinical trials. You will design and implement EDC systems, develop DM documents, and ensure compliance with ICH/GCP and SOPs.

The role requires 10+ years in clinical data management, strong leadership, and cross-functional collaboration. Candidates should have a BA/BS in life sciences and proficiency with EDC and MS Office 365.