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3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg, Amsterdam 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 Operations

We are looking for a clinical operational expert who can provide clinical operations expertise in support of clinical programs or studies for the development of investigational compounds. As a consultant, you can advise and support our (small) biotech clients with the execution/oversight of their clinical studies and/or programs.

Your responsibilities include:

  • On behalf of the client act as the primary counterpart for the clinical CRO and ensure an efficient working relationship with the CRO
  • Support/develop/manage 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 client

Requirements

  • 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 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
  • Extensive 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
  • Be passionate to make a difference in the life of patients and their loved ones!

Interested?

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