clinical data specialist

☞ Randstad

Aussicht: 120

Update Tag: 25-11-2025

Ort: Beerse Antwerp

Kategorie: IT - Software IT - Hardware / Netzwerk Informationstechnologie

Industrie:

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Jobinhalt

job details

summary

  • beerse
  • contract
  • 40 hours per week
  • group function
    medical
  • reference
    CXRSP-110138
job details

The Janssen Campus in Belgium is a major innovation hub and is part of the pharmaceutical companies of Johnson & Johnson. It brings together a unique mix of expertise, skills and partnerships in research and development (R&D), manufacturing and the launch of new drugs. We are working together to create a future where disease is a thing of the past.

As a Clinical Data Specialist, you will join the Analytical Development Department: PDMS Global Clinical Release and Stability

Interested? Email your resume to bianca.dardenne@professionals.randstad.be

...

The Janssen Campus in Belgium is a major innovation hub and is part of the pharmaceutical companies of Johnson & Johnson. It brings together a unique mix of expertise, skills and partnerships in research and development (R&D), manufacturing and the launch of new drugs. We are working together to create a future where disease is a thing of the past.

As a Clinical Data Specialist, you will join the Analytical Development Department: PDMS Global Clinical Release and Stability

Interested? Email your resume to bianca.dardenne@professionals.randstad.be

  • key responsibilities

    Act as a Single Point of Contact (SPOC) for our external contract labs along with External Alliance Manager SPOC.

    • Ensure GMP compliance with regulatory requirements.

    • Support Analytical Development (AD) departments with their relationship and communication with external laboratories (ECLs) and Contract Development Manufacturing Organizations (CDMOs)

    • Support clinical release and stability (CRS) with capacity planning at preferred external contract labs.

    • Assist with the initiation of Work Orders (WO’s)/Purchase Orders (PO’s) at external contract labs and CDMOs (through the close collaboration with External Alliance Manager, AD project managers, and Contract Management teams.

    • Assist with the scheduling of weekly/monthly analytical meetings with CDMOs and ECLs to support AD project timelines.

    • Support the Stability Project Owners, release planners and AD project managers with project timelines and due date tracking of analytical activities at CDMOs and ECLs

    • Connection with other ECL SPOC colleague and External Alliance manager to ensure adequate capacity planning at external ECL sites for AD activities.

  • qualifications

    • Experience with pharmaceutical analytical testing

    • Experience in small molecule/synthetic chemistry, analytics, and stability.

    • Proven ability to build and maintain customer relationships, shows strong communication skills, internally and externally.

    • Ability to foster team productivity and cohesiveness, and to work collaboratively, internally and externally

    • Experience with GMP guidelines, policies, pharmaceutical legislation and industry practices concerning analytical development in clinical development

    • Knowledge of clinical development processes and phases of development within the pharmaceutical industry.

    • Project management and problem solving skills

    • Background in pharmaceutical QA processes and procedures (i.e. deviation, CAPA, Change Control, Quality Agreements, audits)

    • Bachelor’s degree in chemistry, Pharmaceutical Sciences, Bio-engineering or equivalent.

    • 5 years’ experience in the biopharmaceutical or pharmaceutical industry.

    • Fluency in English, Dutch is a plus

  • key benefits

    In response to your high performance & flexibility, Randstad Professionals offers you an interesting salary package, with some interesting perks such as:

    • Meal vouchers of €7
    • Net representation expenses of €80
    • Hospitalization insurance
    • Car + unlimited fuel card OR kilometer allowance
    • 32 vacations
    • End of year bonus
    • Pension plan
    • ECO vouchers
    • Training opportunities
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Frist: 09-01-2026

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