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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