Medical Data Reviewer
Il y a 6 mois
Job description
**Job Description**:
We are currently seeking a dedicated and experienced Medical Data Reviewer to join our team at Amaris Consulting. This role is designed for professionals with 2 to 7 years of experience, offering an Undetermined Duration Contract in Belgium. As a Medical Data Reviewer, you will play a pivotal role in ensuring the scientific consistency and robustness of clinical data. You will work closely with the Clinical Lead (CL) and Data Management teams, providing essential input from a medical and scientific perspective. This position requires a deep understanding of medical review processes, including both instream and holistic reviews, and the ability to work within a flexible resource model to manage the variability in demand linked to large Phase III clinical studies.
Collaborate with the Clinical Lead for the execution of data management tasks requiring scientific and medical input.
Ensure the clinical data's completeness and consistency from a medical perspective.
Provide input to electronic Case Report Form (e-CRF) specifications and annotated Study Book.
Contribute to the development of Data Cleaning strategy and technical requirements related to medical data aspects.
Participate in the development and completion of the medical review plan and cleaning guidelines.
Act as Subject Matter Expert and support data management and clinical operations to resolve study-specific queries.
Report potential protocol deviations detected during the medical review.
Escalate study risks related to medical review to study core team members.
Support the development and testing of new tools for medical review.
This role is based in Belgium and requires fluency in English. It offers the opportunity to contribute significantly to the success of clinical studies by ensuring the accuracy and integrity of study data.
About You
Master degree in life science, biomedical sciences, clinical research, data management, or equivalent.
Professional experience in Data Management and/or medical review.
Understanding of applicable regulations to clinical research (e.g., ICH/GCP).
Excellent organizational and planning skills, with an analytical and proactive approach.
Detail-oriented with the capability to identify critical study data in complex settings.
Team player with the capacity to adapt to changing environments (organization, process, system).
Adequate level of capability to take up end-to-end Medical Review activities.
Fluency in English, with excellent communication skills.
If you are passionate about contributing to the advancement of clinical research and possess the required skills and experience, we would love to hear from you. Join us at Amaris Consulting and help us ensure the success and integrity of clinical studies.
What can you expect?
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7500 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
**Brief Call**: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities
**Case study**: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
We look forward to meeting you
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