Beschreibung
Data Manager (m/f/d)
Reference: -en
Start: 01/20
Duration: 6 MM
Main tasks:
- 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 expert 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 the 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
- Continue to be accountable for quality and where needed, provide support in the form of business and technical expertise to the 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 the 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
- 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 the data to ensure high quality results
Main qualifications
- BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics OR equivalent industry experience
- Experience in leading CDM study teams and maintaining oversight of all start-up, conduct and close-out activities for multiple or complex studies, ensuring fit for purpose quality (including oversight of FSPs, Vendors, CROs and Collaborative Groups)
- Experience in leading the collection of clinical trial and/or Real World Data
- Good understanding of molecule and disease area strategies, healthcare environments, as well as strong scientific and technical expertise
- Knowledge of CDISC data standards
- Knowledge of ICH-GCP and working in regulated environments
- Demonstrated leadership capabilities around decision-making, negotiation, motivation (self and others) and influencing
- Experience with data analytics and/or visualization tools and techniques
- Demonstrated entrepreneurial mindset and self-direction, ability to mentor others and willingness to learn new techniques
- Knowledge of biological principles, display interest and demonstrate scientific curiosity including an understanding of data types and their scientific use (clinical, biomarker, WGS, RNA-seq, etc.)
Main advantages:
- You will work in an international environment
About us:
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.
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My contact person:
Athina Hondroulidou
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