Lead Clinical Data Management Specialist

2070 Gilead Sciences Ireland UC; Leinster; On-site; EUR 70,000 - 110,000; Full time

Job summary

Gilead Sciences Ireland UC is seeking a Clinical Data Management (CDM) lead to oversee data capture, editing specifications, and query resolution across clinical studies. You will guide CRF/eCRF design, vendor oversight, and data transfers to ensure high quality data for regulatory submissions.

The role requires strong knowledge of FDA/EMA regulations, ability to manage timelines, and experience mentoring junior staff while collaborating with CROs and site teams.

Qualifications

• PhD or equivalent with CDM or data analytics experience preferred.
• Extensive CDM experience and ability to deliver with timelines.

Responsibilities

• Serves as lead for one or more studies or projects of increasing complexity, including cross-functional groups.
• Reviews study protocols and assists site coordinators, investigators, and field staff.
• Identifies, tracks, and resolves CDM queries and issues.
• Leads design and implementation of CDM processes with vendors, including data entry, quality checks, transfers and reporting.
• Trains and mentors colleagues in CDM processes and tools.
• Ensures regulatory compliance and supports submissions.

Skills

CDM leadership

FDA/EMA regulations knowledge

Project management

Communication

Fast learner

Flexibility/adaptability

Travel readiness

Education

PhD in life sciences

MA/MS in life sciences

BA/BS in life sciences

Job description

Gilead Sciences Ireland UC is seeking a Clinical Data Management (CDM) lead to oversee data capture, editing specifications, and query resolution across clinical studies. You will guide CRF/eCRF design, vendor oversight, and data transfers to ensure high quality data for regulatory submissions.

The role requires strong knowledge of FDA/EMA regulations, ability to manage timelines, and experience mentoring junior staff while collaborating with CROs and site teams.