Study Data Manager
An excellent multinational healthcare company is seeking a skilled Study Data Manager, to be based in their office in the desirable area of Basel. The organisation is known internationally for their work in pharmaceuticals and diagnostics and their focus on scientific advancement. This is a chance to join a top healthcare organisation who provide an innovative range of diagnostic solutions and medicines.
- Working 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.
- Collaborating with peers within the function and across the organisation to identify, design and execute fit for purpose data management solutions, adhering to F.A.I.R. (Findable, Accessible, Interoperable, Reusable) principles.
- Ensuring 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.
- Contributing to functional, cross functional, enterprise-wide or external initiatives that shape our technical landscape, business and healthcare environments.
- In charge of making sure the data coming in is proper, compliant and delivered on time, including includes data review & cleaning.
- Overseeing both internal and external stakeholders (supplier in India amongst other).
- Developing 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.
- Partnering 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.
- Acting as experts for data collection, advising teams and stakeholders on best practices and proposing innovative solutions.
- Ensuring a high quality of data and compliance with applicable pharma industry regulations and standards.
- Staying 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.
- Using data surveillance tools and strategies to provide aggregate level reviews designed to identify patterns or anomalies in our data to ensure high quality results.
- Organisation and integration of data collected from various sources. Maintain value of data through application of FAIR (Findable, Accessible, Interoperable, Reusable) principles.
- Partnering 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.
- Collaborating and contributing 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.
- Offering 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.
Skills and Requirements:
- 2 years of experience with Data Collection system (e.g. eCRF and others) in pharma
- 2 years of experience with data management (e.g. data cleaning, data review)
- 1 year of experience in Clinical Development (early phases preferred)
- Project Management skills (track record of on time delivery for multiple requests and stakeholder management).
- Knowledge of CDISC data standards.
- Knowledge of ICH-GCP and working in regulated environments
- Experience in a global matrix environment is a plus
- Good understanding of molecule and disease area strategies, healthcare environments, as well as strong scientific and technical expertise is a plus
- 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.
- Experience of Data Collection System in Clinical Development (eCRF etc) and able to translate a protocol into Case Report Forms.
- Project management skills are highly appreciated to be able to manage multiple stakeholders, deadlines and work streams.
- Clinical Development in pharma experience is necessary
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 Tom Magenis at 0203 854 1050 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.