Study Data Manager
An excellent multinational healthcare company is seeking a skilled Study Data Manager, based in their office in the desirable area of Basel. This is a chance to join a top healthcare organisation who provide an innovative range of diagnostic solutions and medicines.
- Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies, projects, and coding responsibilities, including the implementation and adoption of new technologies.
- 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 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.
- 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.
- 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.
- 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.
- Organization and integration of data collected from various sources.
- Maintain value of data through application of FAIR (Findable, Accessible, Interoperable, Reusable) principles.
- Work 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.
- 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.
- 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.
Skills and Requirements:
- BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics, OR equivalent industry experience.
- Knowledge of CDISC data standards.
- Knowledge of ICH-GCP and working in regulated environments.
- 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.).
- 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.
- Extensive [technical] and/or [industry] experience required for senior/principal roles.
- Experience in enterprise level operating systems and familiarity with databases (Relational Database Management System, RDBMS).
- Fluency in programming languages (SAS, R, Python, SQL etc.).
- Some experience with advanced analytics approaches (e.g. machine learning, AI).
- Experience with tools related to technologies required to undertake analyses on large data sources or with computationally intensive steps (SQL, parallelization, Hadoop, Spark, etc.).
- Experience producing interactive outputs (e.g. Shiny, Tableau).
- Contributor to open source packages, libraries or functions.
- Experience implementing reproducible research practices like version control (e.g., using Git, Rmarkdown) and literate programmer.
- Experience with SDTM implementation and CDISC standards.
- Experience with standardized terminologies such as MedDRA and WHODrug ? BSN, RN, RPh, Pharm D, PA or other applicable health professional qualification preferred or previous practical and theoretical experience of clinical coding.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emma Adams at +44 203 854 3893 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.