Do you have experience in Pharma and Clinical Data Management? Are you fluent in English (French and Italian = asset)? Do you want to have, as the next step in your career, a role as an Oversight Data Manager? Then we have your dream job!"
The Oversight Data Manager leads a team of Study Data Managers for preclinical, clinical and epidemiological end-to-end data management activities for their assigned project(s).
This role ensures CRO data management deliverables are at the top of industry standards with respect to quality and timelines.
- Direct and main responsible to deliver DM services for a study or a group of studies by leading a team of CRO resources.
- Manages and conducts oversight of CRO deliverables (technical & data) to ensure they are in line with the Task Order and expectations of the client.
- 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.
- Understand, mediate and solve complex issues related to DM deliverables and escalate as required.
- Act as advisor to the Study Lead on the data management strategy from protocol to delivery of the clinical database.
- Provides input to study design, the clinical protocol, study planning and review of study documents.
- Ensures training on the protocol to the CRO resources working on the study. Responsible for managing the outsourced data management activities during the execution phase and ensuring that they are delivered as mutually agreed with the study teams.
- Responsible for leveraging the learnings (success or failure) after study execution to implement, in their area of responsibility, or propose, improvements for the future.
- Provide reports, risk management plans, status updates, feedback and advice to key stakeholders on study progress.
- Provide input into CRO Governance, budget control and resource forecast to the Performance and Outsourcing Manager.
- Ensure DM deliverables are in compliance with SOPs and regulatory guidelines.
- Develop and maintain excellent professional relations with the clinical teams and other key stakeholders.
- Clinical Research or Information Systems experience with end to end study responsibility
- Good Project Management including risk management skills
- Experienced in Data Management and Clinical Systems
- Good understanding of regulations including ICH-GCP
- Good communication, influencing and negotiation skills within a matrix environment
- Good problem solving and project delivery skills
- Master in Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent
- Fluent English (spoken and written)
- French and Italian a plus
- Full-time position
- A balanced salary package based on your capabilities and experience, including meal vouchers.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 18129