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3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and Oss. We are dedicated to the development of (bio-) pharmaceuticals and diagnostics. Our team of experts covers the key areas of pre-clinical, clinical, CMC, regulatory affairs and project management. In addition, we provide out-licensing and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups.

Consultant Clinical Development – Clinical Operations

For the various projects that we are running for our clients, we are looking for a consultant Clinical Development, able to provide clinical operations expertise in support of clinical programs and/or studies for the development of investigational (bio)pharmaceutical compounds.

Your responsibilities include:

  • Act as primary counterpart for vendor(s); act as sponsor representative being ‘spider in the web’ on behalf of the sponsor and responsible for vendor oversight
  • Development and management of study budget, study planning, and study metrics
  • Provide input on essential documents, including Clinical Trial Protocol, Informed Consent, etc.
  • (Support) execution of clinical trials according to timelines and within budget
  • (Support) site relationships, clinical trial registration, eCRF development, data collection (ensuring completeness, accuracy, and consistency), protocol issue management, newsletter, insurance etc.
  • (Support) organization investigator meetings, DSMB meetings, advisory board meetings, KOL meetings, advisory board meetings, KOL meertings etc.
  • (Support) vendor selection process
  • (Support) vendor management
  • Being a clinical operations representative in a cross functional collaborative environment
  • Coordinating of project management activities to ensure timely, uniform and quality delivery of the services provided to our clients

Requirements & qualifications

  • Relevant academic background in biomedical field
  • A minimum of 5 year experience in the biotech or pharmaceutical industry. Experience in innovative small biotech is a prequisite
  • Up-to-date knowledge of legislation and regulations and ICH-GCP guidelines
  • Evidence of being able to create, execute and proactively manage clinical processes to ensure quality, timeline, resources, and budget goals are met
  • Experience as clinical trial lead
  • Flexible and resilient
  • Ability to work independently and in a team environment
  • Capable of effectively managing multiple deadlines and projects
  • Ability to adapt to rapidly evolving situations and needs
  • Strong commitment to delivering high-quality work
  • Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality, and ability to put yourself in the position of our clients
  • Strong Excel skills


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