Job Description

Medical Data Reviewer

The Medical Data Reviewer collaborates with the Clinical Lead (CL) for the execution of data management tasks requiring a scientific and medical input. He/she is responsible for the scientific consistency and robustness of clinical data and ensures that the study data are complete and consistent from a medical perspective, under the accountability of the CL.

The Medical Data Reviewer is a main interface between the clinical lead and the Data Management teams.

Key Responsibilities:

Study set up activities

• Provide input to electronic Case Report Form (e-CRF) specifications and annotated Study Book
• Compare the protocol/eCRF for the consistency from a medical review perspective
• Provide input into Data Cleaning strategy and Data cleaning technical requirements related to the medical data aspects on the following items:
• Automatic checks/queries
• SAS checks/queries
• Manual checks/queries
• Individual data listings
• Patient profile specifications, if applicable
• Provide input related to the medical data aspect in the development of eCRF completion guidelines.
• Medical review
• Medical review cleaning guidelines
• Cleaning strategy and timing Participate to the elaboration of the cleaning strategy and timings.
• Participate as per business need to different meetings to ensure proper planning, execution and control of the medical review.

Study specific set-up of medical review tools

• Provide business requirements for customization of the visualization/tracking tool used for medical Review as per study design requirements.
• Support the development of the Patient Profile.

Study cleaning phase

• Act as Subject Matter Expert and support data management and country clinical operations to resolve study specific queries.
• Provide input on checks generated by automatic cleaning in iDRP/Data Cleaning Strategy.
• Perform manual cleaning from medical perspective
• Reports Follow up progress of manual medical review through status reports.
• Escalate study risks related to medical review to study core team members.

End of cleaning

• Contribute to edits/review of final version of data medical review cleaning guidelines
• Participate in Pre-analysis meeting
• Ensure availability of cleaned medical listings for filing with CL.
• Act as Subject Matter Expert in process and system enhancements (as per business need)
• Support the development and testing of new tools for medical review
• File essential documents related to medical review activities with CL

Minimum/Preferred Level of Education:

• Master degree in life science, or equivalent acquired experience
• Area of specialization: Life sciences or Biomedical Sciences, Clinical Research, Data management, Medical review
• Fluency in English is mandatory

Job-Related Experience

• Professional experience in medical review and/or Data Management (set-up and management of databases is an asset)
• Need to understand applicable regulations to clinical research (eg. ICH/GCP)

Level of Job-Related Experience required

• Organizational and planning skills, analytical mind, pro-active and assertive
• Capability to clearly identify critical study data in complex setting
• Understanding of medical background linked to the disease studied and related events
• Detail-oriented
• Team player
• Capacity to adapt to changing environment (org, process, system)
• To have adequate level of capability to take up E2E MR activities at term

What we offer

At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.