Clinical Applications

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.