Clinical Data Manager, Hertfordshire
Zest Scientific has been instructed to identify a number of Clinical Data Management professionals with extensive programming experience coupled with real world and clinical trial data expertise.
This is a highly impactful role where you will develop clinical data management strategies for complex projects, 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.
- BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics
- Knowledge of CDISC data standards.
- Knowledge of ICH-GCP and working in regulated environments.
- Project Management skills.
- 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).
- 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.
- 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.
- 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.
- Organisation and integration of data collected from various sources.
- 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.
- 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.
Global, therapeutically focused Pharmaceutical Organisation
Our client is committed to securing the services of the right candidate and is flexible with regards to the remuneration package available. Zest Scientific is working to a strict deadline so in order to be considered for this opportunity please apply now and your application will be reviewed immediately.
Contact: Neil Dewsbury
Telephone: 0114 238 1728