Collaborate with peers within the function and across the organization to identify, design and execute fit for purpose data management solutions, ensuring FAIR principles are adhered to
Act as experts for data collection and acquisition, advising teams and stakeholders on best practices and proposing innovative solutions. e.g. the collection of new data types (e.g. emergent biomarkers), new technologies (e.g. sensors), and new data sources (e.g. RWD, EMR)
Partner with and provide oversight of data management deliverables (e.g. Work-Packages) to our Functional Service Providers (FSPs) and vendors.
Provide Quality Assurance on tasks as applicable to ensure a high quality of data and compliance with applicable pharma industry regulations and standards
Proactively manage timelines and track decisions, ensuring successful delivery of the study work packages carried out at FSPs and continue to be accountable for quality and where needed, provide support in the form of business and technical expertise to our FSPs
Oversee FSP in Sample management and eManifest process, ensuring timely, proactive resolution of queries
Proactively engage with stakeholders across the business to understand their needs and influence their understanding of decisions made in our function. Inform stakeholders of status of key deliverables and act on changing milestones
Partner with stakeholders to understand their data insight needs and offer Data Management solutions
Demonstrate a strong understanding of the data flow from collection through to analysis and filing
Partner with relevant functions for external data vendor selection and management and oversee development of data transfer agreements with vendors ensuring use of standards, fit-for-purpose data models and transfer intervals
Use data surveillance tools and strategies to provide aggregate level reviews designed to identify patterns or anomalies in our data to ensure high quality results
Collaborate and contribute to functional/cross-functional initiatives or goals to promote new ways of working, including emerging technologies and enable broader and more effective use of data to support the business.
Profound experience in Data Management (whether CRO or sponsors)
Experience in Clinical Data Management for start-up, conduct and close-out activities for multiple or complex studies
In-depth experience in Clinical Development
Experience with CDM oversight, leading and maintaining activities
Experience with electronic systems such as RAVE, Spotfire, CDISC
BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics OR equivalent industry experience
You will work in an international environment
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.