Clinical Solutions Associate

Planet Pharma

Brussel

On-site

EUR 65,000 - 90,000

Full time

2 days ago
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Job summary

Planet Pharma is seeking an experienced Clinical Solutions Associate to oversee clinical applications, data repositories and integrations within a global pharmaceutical environment. You will partner with Clinical Sciences, Operations and IT to support system changes, reporting and validation.

The role focuses on improving data quality, streamlining processes and enabling better decision-making across trials and programs, with opportunities to lead workstreams and mentor teammates.

Qualifications

  • Minimum five years in a pharmaceutical or CRO setting.
  • At least three years in clinical data or technology within Drug Development or Life Sciences.
  • Experience with clinical systems such as EDC, CTMS, TMF, MDR/CDR, COAR, BI reporting or dashboards, and system integrations.
  • Three years’ GxP and system validation experience.
  • Knowledge of clinical processes, GCP and GCDMP.
  • Strong project management, problem-solving, organisation and communication skills.
  • Proficiency in English and the ability to collaborate effectively with global teams.
  • Experience creating processes, SOPs or related documentation.

Responsibilities

  • Oversee clinical applications and repositories, including CTMS, eTMF, EDC/TMS, CDR, EDMS, BI tools and dashboards.
  • Support system upgrades and change requests throughout the system development life cycle, from requirements gathering through implementation, training and maintenance.
  • Document business outcomes, data integrations and service-level expectations.
  • Provide operational reporting and dashboards to help clinical teams identify data issues, review study and programme metrics, and analyse activity across projects and trials.
  • Collaborate with IT and global teams on planning, prioritisation, system documentation and validation.
  • Lead or contribute to workstreams, taskforces and stakeholder meetings focused on improving processes and reducing duplication.
  • Evaluate new technologies and advise on their potential business value, risks and benefits.
  • Support audits and inspections, and provide training, mentoring and guidance as needed.

Skills

Project management
Data analysis
Communication
GxP compliance
English proficiency

Tools

EDC
CTMS
TMF
MDR/CDR
COAR
BI reporting
System integrations

Job description

Clinical Solutions Associate

Help shape the systems and data that enable high-quality clinical development worldwide. In this role, you’ll work across clinical applications, data repositories and global teams to improve data quality, streamline processes and support better decision‑making.

Overview

We’re seeking an experienced Clinical Solutions Associate to provide oversight of clinical applications, system integrations and data repositories within a global pharmaceuticalenvironment. You’ll partner with Clinical Sciences and Operations, Information Technology and stakeholders across functions to support system changes, reporting, validation and continuous improvement.

Key Responsibilities
  • Oversee clinical applications and repositories, including CTMS, eTMF, EDC/TMS, CDR, EDMS, BI tools and dashboards.
  • Support system upgrades and change requests throughout the system development life cycle, from requirements gathering through implementation, training and maintenance.
  • Document business outcomes, data integrations and service-level expectations.
  • Provide operational reporting and dashboards to help clinical teams identify data issues, review study and programme metrics, and analyse activity across projects and trials.
  • Collaborate with IT and global teams on planning, prioritisation, system documentation and validation.
  • Lead or contribute to workstreams, taskforces and stakeholder meetings focused on improving processes and reducing duplication.
  • Evaluate new technologies and advise on their potential business value, risks and benefits.
  • Support audits and inspections, and provide training, mentoring and guidance as needed.
Must-Have
  • At least five years’ experience in a pharmaceutical or CRO setting.
  • At least three years’ relevant experience in clinical data or technology within Drug Development or Life Sciences.
  • Experience with clinical systems such as EDC, CTMS, TMF, MDR/CDR, COAR, BI reporting or dashboards, and system integrations.
  • Three years’ GxP and system validation experience.
  • Knowledge of clinical processes, technical frameworks, Good Clinical Practice and Good Clinical Data Management Practices.
  • Strong project management, problem‑solving, organisation and communication skills.
  • Proficiency in English and the ability to collaborate effectively with global teams.
  • Experience creating processes, SOPs or related documentation.

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