Medical Informatics Manager/Digital Medicine Study Manager - FSP - Remote

Parexel FSP are currently recruiting for an experienced Medical Informatics Manager/ Digital Medicine Study Manager in the UK. This is a 100% remote position and is dedicated to one of our key global sponsors.

In this position you will be an invaluable resource responsible for acquiring, processing, and reviewing patient data and records, organizing clinical data forms, implementing data management plans including data preparation and validation activities and define ways to improve operational processes for these activities.

You will act independently and in collaboration with study teams seeking to develop and validate novel digital endpoints across different therapeutic areas.

Some specifics about this advertised role

100% homebased position

• Responsible for mapping local study dictionaries sponsor standards
• Participate and contribute to the development of operational plans to ensure data quality and completeness
• Develop, Implement, and Conduct data quality checks as needed for work/studies
• Work closely with the various stakeholders to understand evolving project portfolio needs, and integration into the systems and requirements; supporting studies with a wide range of disease domains.
• Contribute technical expertise toward the design, implementation, and scaling up of sensor systems and analytics
• As a medical informaticist, ensure collection, organization, curation, storage and safeguarding of patient data from sponsor lab, asset teams, and external collaboration studies.
• Contribute to the overall architecture of the existing data pipelines and workflows, recommends and implements improvements
• Track emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality
• Manage own time to meet agreed targets
• Work under general supervision. Performs assignments using established procedures and general instruction
• Share learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

What we are looking for in the this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role.

• Master’s degree in Health Informatics, Computer Science, Information Systems, or similar field

A minimum of 5+years of technical experience, including:

• Python
• Unix/Linux environments
• Version control systems (ex. Git)
• AWS or other cloud-based development
• Electronic data captures (EDC) solutions, e.g., REDCap, Encapsia, Oracle Clinical, Medidata Rave.
• Familiarity with pharmaceutical informatics standards like CDISC and MedDRA GCP
• Strong interpersonal and collaboration skills
• The ability to build consensus and be agile to changing circumstances and priorities

• Hands-on experience with Clinical Data Management, including Case Report Form (CRF) design, CRF annotation, database design, data collection, data-entry, data validation, discrepancy management, medical coding, data extraction, database locking, and regulatory requirements

Preferred Qualifications:

• Clinical trial experience using and deploying digital health technologies
• Experience with electronic data captures (EDC) solutions, e.g., REDCap, Medrio
• Familiarity with medical informatics standards like CDISC
• Experience with AWS or other cloud-based development
• Experience processing large data sets (including from digital health technologies) in a distributed computing environment
• Experience with SQL or NoSQL-based technologies

• Comprehensive understanding of the landscape of data structures, medical ontologies, interoperability standards, and data processing tools

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