Senior Clinical Data Management Lead

Biopharma Careers; Dublin; On-site; EUR 110,000 - 140,000; Full time

Job summary

Gilead Sciences, Inc. is seeking an experienced CDM lead to manage data capture, quality and reporting across one or more clinical studies. You will design CRF/eCRF, review protocols, and oversee vendor data transfers to ensure high-quality data for analysis and submissions.

Responsibilities include leading CDM activities, training CROs and staff, and ensuring compliance with FDA/EMA regulations and data standards throughout study timelines.

Qualifications

• PhD or advanced degree with relevant CDM experience preferred.
• Extensive CDM or related data management experience desired.
• Strong knowledge of regulatory requirements (FDA/EMA) and data standards.

Responsibilities

• Lead CDM activities for one or more clinical studies.
• Review study protocols and assist site staff in data collection.
• Identify, track, and resolve CDM queries and issues.
• Act as a point of contact for study management and Clinical Development on CDM matters.
• Collaborate with colleagues to meet deliverables and timelines for data acquisition and reporting.
• Ensure completeness, accuracy and consistency of routine clinical data.
• Lead design and implementation of CRF/eCRF designs.
• Educate and train CROs, vendors and investigators on CDM requirements.
• Support regulatory submissions for assigned projects.

Skills

CDM leadership

CRF/eCRF design

FDA/EMA regulations

EDC systems

Data quality assurance

Vendor management

Education

PhD in life sciences or related

MA/MS in life sciences or related

BA/BS in life sciences or related

Tools

EDC platforms

CDM software

Data management tools

Job description

Gilead Sciences, Inc. is seeking an experienced CDM lead to manage data capture, quality and reporting across one or more clinical studies. You will design CRF/eCRF, review protocols, and oversee vendor data transfers to ensure high-quality data for analysis and submissions.

Responsibilities include leading CDM activities, training CROs and staff, and ensuring compliance with FDA/EMA regulations and data standards throughout study timelines.