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.
This role ensures CRO data management deliverables are at the top of industry standards with respect to quality and timelines.
The Senior Oversight Data manager has the following key 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.
• Minimum Bachelor degree Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent
• Fluent in English (spoken and written)
• French and Italian a plus
• Master degree in Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent
• Minimum 5 years Clinical Research or Information Systems experience and demonstrated oversight skills
• Ability to apply knowledge to manage and improve complex processes and systems in the pharmaceutical industry.
• 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
GSK is deeply committed to professional and personal development offering employment opportunities across a diverse collection of businesses and geographies. So you'll flourish in an inspiring environment where personal growth plays a vital part in the changing face of the business. Most of all, you'll enjoy the sense of purpose that comes from leading change in an industry that touches millions every day.
• Possibility of developing within the role and company's structure
• Career in one of the leading global healthcare companies
• Supportive & friendly working environment
• Corporate culture based on our values: patient focus, integrity, respect and transparency
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Back to top