Clinical Data Specialist

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

• Location: Home-based / remote (cannot consider candidates located in the UK, Germany, or the Netherlands)
• Contract length: Initial contract until December 2027

Our global biopharmaceutical client is seeking a Clinical Data Specialist to provide oversight of key clinical systems, applications, and data repositories supporting global clinical development programs. This position will act as a subject matter expert across clinical technologies, ensuring data quality, supporting system enhancements and integrations, delivering operational reporting and dashboards, and collaborating with cross-functional stakeholders to drive continuous improvement across clinical operations processes and systems.

Key responsibilities:

• Oversee and support clinical applications including CTMS, eTMF, EDC, Clinical Data Repositories, BI reporting platforms, and associated system integrations.
• Partner with IT and business stakeholders on system upgrades, enhancements, validation activities, change requests, and SDLC processes from requirements gathering through implementation and training.
• Develop and maintain operational reporting, dashboards, and data visualisations to support clinical teams, leadership, and cross-functional decision making.
• Lead stakeholder meetings, user groups, and cross-functional workstreams to optimise clinical technology utilisation and improve business processes.
• Support audits, inspections, SOP development, process improvements, and ensure compliance with GCP, GxP, and applicable regulatory requirements.

Key requirements:

• Minimum 5 years' experience within a pharmaceutical company, biotechnology organisation, or CRO environment.
• At least 3 years' hands-on experience working with clinical technologies such as CTMS, EDC, eTMF, CDR, MDR, BI reporting platforms, or related clinical systems.
• Strong understanding of clinical development processes, system validation activities, GxP compliance, and Good Clinical Practice (GCP) requirements.
• Proven ability to manage multiple projects simultaneously while engaging and influencing global stakeholders across different functions and regions.
• Excellent communication, problem-solving, and project management skills, with the ability to work independently and drive continuous improvement initiatives.

About Planet Pharma:

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com