Are a medical doctor who has recently completed a Radiology or Nuclear Medicine training program or if you are an experienced radiologist with up to 10 years of clinical imaging background and are looking for a new career direction with impact
Then check out this great opportunity to join us as a Diagnostic Radiologist & Trial Physician
Who are we
DICE is a clinical research organization (CRO), that carries out all biometrics aspects of clinical research for pharmaceutical and biotechnology companies, from data management to processing statistical analysis and clinical study report compilation. DICE provides (electronic) data capture, data management, statistics, PK analysis, central imaging reviews, medical monitoring and medical writing services. Check us out on: www.dice-cro.com.
What makes DICE unique
• We offer an entrepreneurial environment where you get to partner with start-ups as well as well-established companies. You will be instrumental in their success to bring new medicines to market safeguarding the correct process both from an ethical as statistical point of view;
• You will be working on a variety of projects and contribute to different aspects ranging from design to final delivery;
• We are committed to your continuous learning and development;
• Collaboration and team spirit define our culture and strong values like service, excellence, integrity and ownership – ensure we deliver superior results for our customers.
What will you be doing
As a Diagnostic Radiologist you will be responsible for imaging aspects of clinical studies:
- Definition of imaging endpoints relevant to the clinical objectives of the clinical trial and clinical development program, consistent with ICH, FDA and EMA guidelines;
- Translate the imaging endpoints in scanner requirements and qualifications of site staff. Assist in the site selection process;
- Review the quality, appropriateness, and completeness of imaging scans at each timepoint;
- Perform review, measurements, and interpretation of acquired imaging scans according to protocol-specific interpretation criteria (e.g. RECIST, IRECIST, or other internationally validated imaging interpretation criteria);
- Generate official interpretations (final reports) of each imaging scan and assign a comprehensive, overall response to treatment evaluation;
- Ensure the correct and complete transfer of imaging scans and final reports between the local reviewing platform and the central server allocated for the trial;
- Organize internal quality control processes relevant to the clinical studies and the activities of the company.
As a trial Physician you will be responsible for all medical aspects of clinical trials and clinical development programs:
- Defining of inclusion and exclusion criteria for populations to be enrolled in clinical trials. During the recruitment phase you will be the point of contact for investigators to answer questions on eligibility for participation in a clinical trial;
- Defining of clinical assessments, including detailed medical procedures consistent with guidelines issued by FDA, EMA and other competent authorities. You will be responsible to describe these assessments in the protocol, training material and clinical study report;
- Define the setup for clinical coding: MedDra and WhoDrug. Organize the coding and be accountable for the quality of the clinical coding and organize quality control as appropriate;
- Be responsible for the medical review and coherence of medical information collected in the context of a clinical study or clinical development program;
- Define and review patient data lists and profiles for safety assessments during clinical trials, for example for Data Safety Monitoring Boards and safety analysis. Participate to DSMB or other medical safety boards as appropriate;
- Redaction of safety sections of clinical study reports and CTD modules, for examples description of adverse events of special interest, serious adverse events, safety conclusion in the light of the study objectives and literature;
Ideal work experience and education
- Medicine Degree and Specialist Certification in Diagnostic Radiology/Nuclear Medicine with Radiology training.
- Working proficiency in interpreting body CT, MRI or PET/CT scans with and without contrast enhancement.
- Good working proficiency with Windows-based or Mac OS-based Radiology reviewing software platforms.
- Knowledge of and clinical work experience with the established imaging interpretation criteria, i.e. RECIST iRECIST or other internationally validated imaging interpretation criteria.
- Proficiency in producing reproducible and consistent measurements of target and non-target lesions as well as radiological response evaluations across multiple patients and at different evaluation time points.
- Good verbal and written skills in English.
- Knowledge of ICH guidelines, for example ICH E.3, E.6, E.8, E.9, E.10, M.4 is considered as a plus
The position is available for medical doctors who have recently completed a Radiology or Nuclear Medicine training program as well as for experienced candidates with up to 10 years of clinical imaging background.
What makes you stand out
• Focus with an eye for detail
• Excellent verbal and written communication skills in Dutch or French and English
• Achievement orientation and high energy
• Entrepreneurial mindset with a customer obsession
• Can do attitude and the flexibility to engage in a variety of tasks
• Growth mindset to continuously learn and stay on top of latest developments
• The ability to work autonomously, as well as collaboratively in a team, in an atmosphere where giving constructive feedback is a must
What we offer
• A competitive package with extra-legal benefits (company car, mobile phone, meal vouchers, and insurances package).
• A young and dynamic work environment
• A strong commitment to your professional growth and continuous development
• An easy to reach office & possibilities to work from home
• We promote flexibility in working arrangements.
Your success will be the result of your entrepreneurial drive, passion for delivering superior results and your desire to fulfil the commitments to clients and co-workers.
Take your career to the next level, and apply now
Check us out on: https://www.dice-cro.com/