If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at a Digital Medicine and Translational Imaging Data Manager Digital Health to join us in Spain dedicated to a single sponsor. We are looking for hard‐working, talented, high‐caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long‐term success.
As the company that conducts vital clinical studies for sponsors, including the world's leading biotech's and top 50 pharmaceutical companies, we offer you enormous security and long‐term prospects.
You will work from your home office base, supporting studies within their country or region. 'Manageable sites, manageable protocols' is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.
On this role you will be 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 defining 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.
Responsibilities
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
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, asset teams, and external collaboration studies is consistent with 21CFR part 11
Contribute to the overall architecture of the existing data pipelines and workflows, recommend and implement improvements
Track emerging study data and work closely with the data science team to ensure the effectiveness of tools and data quality
Manage own time to meet agreed targets
Work under general supervision. Perform assignments using established procedures and general instruction
Share learnings with key stakeholders and the scientific community through presentations and peer‐reviewed publications.
Minimum Qualifications
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 capture (EDC) solutions, e.g., REDCap, Encapsia, Oracle Clinical, Medidata Rave
Familiarity with pharmaceutical informatics standards like CDISC and MedDRA
GCP knowledge
Strong interpersonal and collaboration skills
Demonstrate 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 capture (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.
Who are ParexelPAREXEL 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.
For an immediate interview, please contact marta.kuniewicz@parexel.com .
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