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

Interested?

Contact Us

Please attach your CV to our contact form!