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 cover 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.
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.
- 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 investigator meetings, DSMB meetings, advisory board meetings, KOL meetings 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
- Relevant academic background in biomedical field
- A minimum of 5 year experience in the biotech or 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!
- Be part of a dynamic group of experienced drug development experts
- Enjoy a company culture that prioritizes work/life balance
- Flexible remote working options
- Competitive salary along with a bonus plan• Excellent secondary benefits, including pension
- Engage in diverse projects and work with a wide range of clients
- Work alongside with 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: [email protected]
Acquisition is not appreciated!
