For one of our clients located in the Walloon Brabant, we are looking for an Oversight Data Manager.
As Oversight Data Manager, you coordinate a team of Clinical Data Managers for preclinical, clinical and epidemiological end-to-end data management activities for their assigned project(s) and you act as a Subject Matter Expert. This role ensures CRO data management deliverables at the top of industry standards with respect to quality and timelines.
- You are responsible to deliver DM services for a study or a group of studies by leading a team of CRO resources. You manage and conduct oversight of CRO deliverables (technical & data) to ensure they are in line with expectations.
- You are the first point of escalation for the study teams where the Clinical Data Manager at the CRO is the first point of contact at a study level. You understand, mediate and solve complex issues related to DM deliverables and escalate as required.
- You act as advisor to the Study Lead on the data management strategy from protocol to delivery of the clinical database. You provide input to study design, clinical protocol, study planning and review of study documents. You ensure training on the protocol to the CRO resources working on the study. You are responsible for managing the outsourced data management activities during the execution phase and you ensure that they are delivered as mutually agreed with the study teams. You are responsible for leveraging the learnings (success or failure) after study execution to implement, in their area of responsibility, or propose, improvements for the future.
- You provide reports, risk management plans, status updates, feedback and advice to key stakeholders on study progress. You provide input into CRO Governance, budget control and resource forecast to the Performance and Outsourcing Manager.
- You ensure DM deliverables are in compliance with our client's SOPs and regulatory guidelines.
- You act as Subject Matter Expert in supporting Business Excellence in the implementation of new processes, trainings, systems, vendor quality assessments, audits and inspections.
- You develop and maintain excellent professional relations with the clinical teams and other key stakeholders.
- You have a Master degree in Engineering, Life Sciences, Computer Sciences, Mathematics, Physics or equivalent
- You have minimum 3 years of experience as a Clinical Data Manager or you have 3 years of experience as a Clinical Project Manager with specific skills in Data Management.
- You are fluent in English.
- You have a good understanding of regulations including ICH-GCP
- You have proven ability to manage oversight of end to end outsourced processes
- You have Good Project Management and Vendor Management (including risk management) skills
- You have a good knowledge of global clinical trial practices, procedures, and data presentation
- You have good communication, influencing and negotiation skills within a matrix environment
- You have good problem solving and project delivery skills
- You have good networking skills