Study Data Manager
- Experience Level
Our client is a pioneer in Drug Discovery and Development. As the world`s largest R&D spender in the pharmaceutical domain, they work in a vast number of drugs & therapeutic areas and are highly recognized internationally. They are also a leader in the field of manufacturing and selling of several drugs for the treatment of Cancer. They are currently looking for a
- 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. 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. 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
Qualifications and Experience:
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required
- 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.
- Demonstrated strong collaboration and excellent communication skills – both written and oral (proficiency in English required).
- Knowledge of CDISC data standards.
- Knowledge of ICH-GCP and working in regulated environments.
- Project Management skills.
- Able to manage multiple requests and priorities.
- 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.