Posted: 5 January 2022

Consultant Clinical Development – Clinical Operations – 3D -PharmXchange

Location: Tilburg, The Netherlands
Hours: 40

Company profile

3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and Oss. We are dedicated to the development of 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.

Job Description

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 meetings 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 and qualifications

  • Relevant academic background in the biomedical field
  • A minimum of 5 years of experience in the biotech or pharmaceutical industry. Experience in innovative small biotech is a pre.
  • 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 a 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

For more information about this vacancy, contact Managing Partner Albert Peters +31 6 28209882

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