Without data you are just another person with an opinion
Over de functie
Yacht Life Sciences has a vacancy for a Senior Oversight Data Manager.
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 proven data management expertise of the Senior Oversight Data Manager will be a key in supporting studies and projects, decision making and driving best practice from a Data Sciences & Clinical Systems (DSCS) perspective. He/she will have oversight of the data management project deliverables and serve as the leader for the Clinical & Epi Core Team (CECT). He/she will manage and track key study metrics to ensure adherence to data management milestones.
The Senior Oversight Data manager has the following key responsibilities:
- Directs and maintains 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 the company's 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.
- Understands, mediates and solves complex issues related to DM deliverables and escalate as required.
- Acts 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 learning (success or failure) after study execution to implement, in their area of responsibility, or propose, improvements for the future.
- Provides reports, risk management plans, status updates, feedback and advice to key stakeholders on study progress.
- Provides input into CRO Governance, budget control and resource forecast to the Performance and Outsourcing Manager.
- Ensures DM deliverables are in compliance with company's SOPs and regulatory guidelines.
- Acts as Subject Matter Expert in supporting Business Excellence in the implementation of new processes, training, systems, vendor quality assessments, audits and inspections.
- Develops and maintains excellent professional relations with the clinical teams and other key stakeholders.
- The role requires to understand complex processes and systems in the pharmaceutical industry.
- Minimum 5 year's of Clinical Research or Information Systems experience and demonstrated oversight skills.
- Experience required to deliver assigned clinical data management tasks in-line with expectations in terms of time and cost and in compliance with DSCS processes .
- Language skills: Fluent English (spoken and written) + French and Italian a plus
- Good communication, 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
We will offer a competitive benefits package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up to date: boosting your career through personal and scientific growth.
The vaccines, medicines and consumer healthcare products that they research and develop can improve people’s health and well-being, ultimately helping them to live life to its fullest and contribute to the prosperity of their communities.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998
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