Clinical Applications & Data Systems Specialist

Pauwels Consulting; Eigenbrakel; On-site; EUR 60,000 - 90,000; Full time

Job summary

Pauwels Consulting partnered with a leading life sciences client in Belgium to provide global oversight of clinical applications and data repositories. You will guide data quality improvements, support system upgrades, and drive strategic technology changes across the SDLC.

You will liaise with clinical teams and IT, ensure compliance with GCP and GxP, and lead stakeholder meetings to streamline processes. Fluent English and 5+ years in pharma/CRO are expected.

Qualifications

• Bachelor's degree or equivalent higher education.
• 5+ years of experience in a pharmaceutical or CRO setting.
• 3+ years of experience with EDC, CTMS, eTMF, CDR and BI reporting.
• 3+ years of experience with GxP and system validation.
• Strong knowledge of Good Clinical Practice (GCP) and Good Clinical Data Management Practices.
• Strong project management skills and the ability to work effectively with global teams.
• Fluent in English.

Responsibilities

• Oversee clinical applications and repositories including CTMS, eTMF, EDC, and BI dashboards.
• Support system upgrades and change requests by collaborating with IT throughout the SDLC.
• Provide operational data reporting and discovery dashboards to help clinical teams identify data-related issues.
• Act as a delegate for the Process Data Owner in the review and approval of system documentation.
• Lead stakeholder meetings and workstreams to streamline business processes and clinical application usage.
• Evaluate new technologies to provide advice on solution selection in alignment with organizational strategy.
• Ensure compliance with international regulations and GCP during audits and inspections.

Skills

Clinical data management

GxP knowledge

Project management

English fluency

Education

Bachelor's degree

Tools

EDC

CTMS

eTMF

CDR

BI reporting

Job description

Our client, a leading life sciences organization, is seeking a professional to provide global oversight of clinical applications and data repositories. This role involves assisting users with data quality and completeness while supporting clinical system upgrades and strategic technological changes.

• Oversee clinical applications and repositories including CTMS, eTMF, EDC, and BI dashboards.
• Support system upgrades and change requests by collaborating with IT throughout the SDLC.
• Provide operational data reporting and discovery dashboards to help clinical teams identify data-related issues.
• Act as a delegate for the Process Data Owner in the review and approval of system documentation.
• Lead stakeholder meetings and workstreams to streamline business processes and clinical application usage.
• Evaluate new technologies to provide advice on solution selection in alignment with organizational strategy.
• Ensure compliance with international regulations and GCP during audits and inspections.

• You have a Bachelor's degree or equivalent higher education.
• You bring 5+ years of experience in a pharmaceutical or CRO setting.
• You possess 3+ years of relevant experience in clinical technology working with EDC, CTMS, eTMF, CDR, and BI reporting.
• You have 3+ years of experience with GxP and system validation.
• You bring strong knowledge of Good Clinical Practice (GCP) and Good Clinical Data Management Practices.
• You possess strong project management skills and the ability to work effectively with global teams.
• You are fluent in English.

Nice to Haves

• Experience in creating new processes, SOPs, and related documentation.
• Ability to engage and motivate application users.