For one of our client located in the Walloon Brabant, we are looking for an experienced Clinical Data Manager.
- Do you have a University Degree in Life Sciences (Master Degree or PhD)?
- Do you have at least 3-5 years of experience in clinical operations or in clinical data management?
- Are you fluent in English (oral and written)?
Then you might be the specialist that we are looking for.
As a Clinical Data Manager, you are responsible to deliver Data Management 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 the Task Order and the company's expectations.
- You are the first point of escalation for the study teams where the Study Data Manager at the CRO is the first point of contact at a study level.
- You understand, mediate and solve complex issues related to Data Management deliverables and escalate as required.
- You act as an advisor to the Study Lead on the data management strategy from protocol to delivery of the clinical database.
- You provide input to study design, the 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 for ensuring 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 Data Management deliverables are in compliance with SOPs and regulatory guidelines.
- You develop and maintain excellent professional relations with the clinical teams and other key stakeholders.
- You have a University degree in Life Sciences (Master degree or PhD) and at least 3-5 years of experience in Clinical Operations or in Clinical Data Management.
- A first experience in the field of Oncology is an asset
- You are fluent in written and spoken English
- You have strong people management skills
- You have excellent communication skills
- You are assertive and have ability to build impactful relationships
- You have excellent organizational and planning skills
- You have a strong analytical mind
- You are a real Team player, you have a strong sense of urgency and you are performance driven.