Medical Data Reviewer Lead

Medical Data Reviewer Lead

Keyrus Group

Waterloo, Belgium

Job Description

Accountabilities for the role of the MDRL:

• Primary point of contact for all aspects related to the management of the outsourced Medical Data Review services.
• Ensure that the services meet the expectations both in terms of quality and timelines. (Manages project timeliness, quality, scope, budget and risks (minimization/mitigation) for all activities in a project).
• People management of vendor’s medical reviewers, includes but not limited to day-to-day management of people, coaching and mentoring, performance management.
• Coordinates project activities with project teams members and ensures that all project team members are aligned with governance strategy and the project management plan.
• Identifies quality issues within the project and put in place appropriate corrective action or action plan.

To manage the vendor’s medical review resources This covers the following activities:

• evaluation/review of need for additional resources, transfer of resources from one project/study to another, hiring of new MDR's.
• Responsible for achieving successful delivery of all activities in the conduct of projects across all therapeutic areas
• Ensures compliance to relevant SOP’s and compliance to appropriate regulations (ICH-GCP, local regulatory requirements.)

Required skills and expected level:

• The MDRL role must be a senior profile, trained in the requirements to the execution of the Services and regulatory requirements such as GCP and ICH guidelines, and with extensive experience in clinical trials.
• The entitled MDRL has proven project and people management as well as strong leadership skills.
• Ideally, should have an experience in Medical Data Review or/and Data Management area.
• Perfect knowledge of current office tools (Excel, Word, Power Point)
• Strong management skills and leadership
• Fluent in English (spoken and written)
• Organized, pro-active and autonomous
• Attention to detail
• Strong interpersonal skills
• Strong oral and written communication skills
• Problem Solving – Can assimilate information and ideas from a wide source to make high quality decisions. Takes a broad overview of the situation / problem or event.

Required level of education

• Master degree in life science, or equivalent acquired experience
• Area of specialization: Life sciences or Biomedical Sciences, Clinical Research, Data management

Required work experience in this role:

• Experience in Medical Data Review/Data Management activities
• Minimum of 3 years of experience in Project Management or certified training in Project Management
• Experience in managing and coaching more junior colleagues in projects

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Belgium      Clinical Data Management      Data, Programming and Statistics      Medical      Keyrus Group