Posted on Mar 13, 2020 by Coopers Group GmbH
For our Pharma Client in the Basel area, we are looking for a
We are looking for a Clinical Programmer to join the Clinical Data Management function. As a Clinical Programmer within the Clinical Data Management (CDM) function, you will work within a team of experts in data life cycle management who acquire and curate data for use in exploratory research, clinical development and evidence generation. You will collaborate with peers within the function and across the organization to identify, design and execute fit for purpose data management solutions, adhering to F.A.I.R. (Findable, Accessible, Interoperable, Reusable) principles. You will ensure the timely completion of data management deliverables and partner with Functional Service Providers (FSPs) and vendors, overseeing and providing technical expertise in the delivery of high quality data. You may also contribute to functional, cross-functional, enterprise-wide or external initiatives that shape our technical landscape, business and healthcare environments. You will need strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to evolve the way we collect and deliver data and to develop and deliver medicines for our patients.
Tasks & Responsibilities
STAKEHOLDER MANAGEMENT: 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.
VENDOR MANAGEMENT: 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.
DATA COLLECTION AND ACQUISITION: Act as experts for data collection, advising teams and stakeholders on best practices and proposing innovative solutions. Ensure a high quality of data and compliance with applicable pharma industry regulations and standards.
PROVIDE DATA SOLUTIONS: Stay current with and adopt emergent data collection, data management, visualisation and provision tools and applications to ensure fit-for-purpose and impactful approaches. Deliver on solutions as needed.
DATA CURATION: Organization and integration of data collected from various sources. Maintain value of data through application of FAIR (Findable, Accessible, Interoperable, Reusable) principles.
SUPPORT ANALYSES: 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.
FUNCTIONAL EXCELLENCE: Collaborate and contribute to functional/cross-functional initiatives or goals to promote new ways of working, including emerging technologies. Enable broader and more effective use of data to support the business.
TECHNICAL CONSULTANT: Offer guidance and advice to peers within the function, to key stakeholders and to FSPs, CRO and collaborative groups on technical solutions to ensure high quality data collection and delivery. Deliver on solutions as needed.
2-4y+ of experience working in a similar position in Pharma/Healthcare sector
Hands-on programming skills in Medidata Rave including C-sharp
Proven experience working with non-CRF/Vendor data
Experience with R, Spotfire, Python
Experience with SDTM implementation and CDISC standards; ideally including CDISC compliant filing, eSubmission support