Oversight Data Manager
Purpose of the mission:
The Senior 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) and acts as a Subject Matter Expert.
The Senior Oversight Data manager has the following responsibilities:
- 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 GSK expectations.
- 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 GSK SOPs and regulatory guidelines.
- Act as Subject Matter Expert in supporting Business Excellence in the implementation of new processes, trainings, systems, vendor quality assessments, audits and inspections.
- Develop and maintain excellent professional relations with the clinical teams and other key stakeholders.
- Bachelor degree / Master.
- Area of Specialisation : Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent
- Minimum 5 years of experience in Clinical Research or Information Systems and demonstrated oversight skills
- Fluent English (spoken and written)
- French is a plus
- Italian is a plus
- Good communication skills
- Influencing and negotiation skills within a matrix environment
- Good problem solving and project delivery skills
- Good networking skills
- Proven ability to manage oversight of end to end outsourced processes
- Good Project Management and Vendor Management (including risk management) skills
- Experienced in Data Management and Clinical Systems
- Good knowledge of global clinical trial practices, procedures, and data presentation
- Good understanding of regulations including ICH-GCP
What we offer
You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science, we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Office Park - Drève Richelle 161 bât L - Waterloo
- Nijverheidslaan 3, - Strombeek Bever