Remote Clinical Data Specialist: CTMS/EDC & Insights

Planet Pharma; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

Planet Pharma is seeking a Clinical Data Specialist to oversee key clinical systems, data repositories, and analytics for global clinical development. You will ensure data quality, support system enhancements, and deliver dashboards for cross-functional decision making.

You will collaborate with IT and biostatistics teams, drive validation activities, and help ensure compliance with GCP and GxP across multiple regions. This role is remote with a global scope.

Qualifications

• Minimum 5 years' experience in a pharmaceutical company, biotechnology organisation, or CRO environment.
• Hands-on experience with clinical technologies such as CTMS, EDC, eTMF, CDR, MDR, BI reporting platforms, or related systems.
• Strong understanding of clinical development processes, GxP, and GCP requirements.
• Ability to manage multiple projects while engaging global stakeholders across functions and regions.

Responsibilities

• Oversee and support clinical applications including CTMS, eTMF, EDC, CDR, BI reporting platforms and integrations.
• Collaborate with IT and business stakeholders on upgrades, validation activities, change requests, and SDLC processes from requirements through implementation and training.
• Develop and maintain operational reporting, dashboards, and data visualisations for clinical teams and leadership.
• Lead stakeholder meetings, user groups, and cross-functional workstreams to optimize technology use and business processes.
• Support audits, SOPs, process improvements, and regulatory compliance (GCP/GxP).

Tools

CTMS

EDC

eTMF

CDR

MDR

BI Reporting Platforms

Job description

Planet Pharma is seeking a Clinical Data Specialist to oversee key clinical systems, data repositories, and analytics for global clinical development. You will ensure data quality, support system enhancements, and deliver dashboards for cross-functional decision making.

You will collaborate with IT and biostatistics teams, drive validation activities, and help ensure compliance with GCP and GxP across multiple regions. This role is remote with a global scope.