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Consultant Clinical Operations

Consultant Clinical Operations

3D-PharmXchangeTilburg, North Brabant, Netherlands
22 dagen geleden
Functieomschrijving

Consultant Clinical Operations

Company profile

3D-PharmXchange is a drug development consultancy company located in Tilburg, Oss and Amsterdam. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem solving and long-lasting relationships. Our team of experts covers the key areas in drug development of non-clinical, clinical, CMC and regulatory affairs. In addition, we provide project leadership and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups and academia. Our mission is to provide true patient-centered smart expert guidance to support the development of safe and efficacious drugs at the highest quality, highest efficiency and lowest costs.

Join our dynamic team – no two days are the same!

Are you ready to step into a role where flexibility, adaptability and problem-solving are key? In our Clinical Operations team, every day brings new challenges and opportunities. From coordinating a diversity of projects to managing unexpected roadblocks, this is a role for those who thrive in a fast-paced, ever-changing environment.

You’ll be working at the heart of clinical research and drug development, ensuring smooth trial execution, collaborating in cross-functional teams, and adapting to shifting priorities. If you enjoy variety, making a real impact, and thinking on your feet, we want to hear from you!

What can you expect :

  • A dynamic work environment with no “typical” day
  • Exposure to multiple projects and stakeholders
  • Fast decision-making and real-time problem-solving
  • Opportunities to innovate and drive efficiencies in clinical trials

Your responsibilities :

  • On behalf of the client be the primary counterpart for the clinical CRO and ensure efficient working relationships
  • Act as the ‘spider in the web’ on behalf of the sponsor, responsible for study / program oversight and vendor management & oversight
  • Support / develop / manage study budget, study planning, study metrics, and vendor selection
  • Provide input on essential study documents, including Clinical Trial Protocol, Informed Consent, etc.
  • Support execution of clinical trials according to timelines, budget and high quality standards
  • Support site relationships, clinical trial registration, eCRF development, data collection (ensuring completeness, accuracy, and consistency), protocol issue management, newsletter, insurance etc.
  • Support organization of meetings for Investigators, DSMB, advisory board, KOL, etc.
  • Support vendor selection process
  • Being a clinical operations representative in a cross functional collaborative environment
  • Coordination of project management activities to ensure timely, uniform and quality delivery of the services provided to our clients

    • Requirements

  • Relevant academic background in biomedical field
  • A minimum of 5 year experience in biotech / pharmaceutical industry. Experience in 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
  • Essential personality skills : pro-active, team player, entrepreneurial, can-do mentality, flexible 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

    • Our Offer

  • Be part of a dynamic group of experienced drug development experts
  • Enjoy a company culture that prioritizes work / life balance
  • Flexible hybrid working options
  • Competitive salary along with a bonus plan
  • Excellent secondary benefits, including pension
  • Work alongside a team of friendly and supportive colleagues

    • If you are a proactive professional who loves variety and enjoys working in a non-standard, high-energy setting, apply today!

    Send your CV and short motivation letter to Margarida Neves, at [email protected].

    Acquisition is not appreciated!