Clinical Project Manager Oncology
VitroScan – Better Informed Treatment Decisions for cancer patients
VitroScan is a Dutch biotech company founded in 2016 and based at the Leiden Bio Science Park. VitroScan develops fast and accurate predictive testing for multiple cancers and treatments to support better informed treatment decisions for cancer patients.
Treatment decisions for cancer patients become increasingly more complex. Innovative new treatment strategies, including immunotherapy, and cellular therapies have the potential to offer great benefit to cancer patients. While established treatments already improved the care for cancer patients since long time. In this continuously changing landscape, diagnostics are crucial to deliver the best treatment for each individual patient. VitroScan develops fast and accurate predictive testing for multiple cancers and treatments.
Our unique technology platform uses high content 3D imaging for sensitive detection of therapeutic responses. Analysis is based on generation of a 3D image stack of the tumor tissue in the assay, followed by segmentation, and subsequent feature extraction for representation of the drug response. VitroScan runs multiple ongoing clinical trials for different indications in collaboration with clinical experts from Dutch and European medical centers. The growing database is correlating ex vivo drug sensitivity and clinical outcome for several cancer types.
The team consist of successful entrepreneurs, experts in the fields of bio informatics, computer vision, programming and 3D cell culture and drug testing, with extensive networks in fields of clinical oncology, pharma, and (bio) information technology.
We are seeking a highly motivated Clinical Project Manager that is keen to make a difference in the life of patients.
As Clinical Project Manager, you will be responsible for the day-to-day execution of VitroScan’s clinical research projects. You will be a key point of contact for external research engagements: accountable for study operations, coordination of patients’ sample collection and shipment, oversight of multiple sites, ensuring that studies are executed in compliance with applicable clinical and regulatory standards and in alignment with our R&D and business needs. The focus of the clinical trial program involves clinical studies to evaluate the performance of VitroScan’s predictive testing solutions.
You will align your work in close collaboration with the bioinformaticians to coordinate data collection and analysis, and the scientists in the lab to align study progress, expected accrual rate and planning of new samples.
This role comes with opportunities to develop clinical operations within VitroScan, as you will be the principal project manager for our clinical development.
Responsibilities (not limited to):
- Development of clinical trial documentation including protocols, case report forms (CRFs), IRB/Ethics submissions, etc.
- Coordination of local and central datamanagement
- Communication of study evaluations and progress to (principal) investigators
- Organization of sample shipment according to the regulations for biological materials
- Evaluation potential investigators, sites and vendors, as applicable
- Development of site training tools, presentations, and logistic protocols
- Tracking of project progress and providing status update reports
- Accurate filing of study documents
- Master's Degree or higher in biomedical science, ideally oncology
- Knowledge of clinical trial design, basic statistics, and data review tools
- Strong data review and interpretation skills
- Data management experience: creating data structures, proactive planning of data formatting, merging across multiple data sources, etc.
- Must have excellent interpersonal and communication skills, including proven verbal, written and presentation skills
- Demonstrable project management, problem-solving and organizational skills
- Fluent in English and Dutch
- Affinity with commercialization of technology
- Legally eligible to work in the country of employment
- Live and work in the Netherlands
- Superb team player: accountable, transparent, efficient, punctual and collaborative
- Be detail oriented, a self-starter and comfortable with a broad set of responsibilities in an innovative, fast paced, small company environment
- Experience in clinical development
- Completed of ICH GCP training
- Knowledge of FDA/IVDR development
- Understanding of laboratory work and bio informatics
By joining a rapidly developing start-up, you will get the opportunity to have an impact on the clinical development of our predictive testing services for cancer patients.
In the meantime, get the opportunities to develop your career. This includes having very diverse tasks, broad responsibilities and to work towards the goals of the team and the company. You will work within a highly motivated team, in an international environment, in close collaboration with hospitals, academia and other companies and take part in driving the current projects towards market ready products. Furthermore, the position is located at a biotech hub in a vibrant and international environment.
For more information or informal enquiries, please contact Willemijn Vader via email@example.com