Digital Medicine and Translational Imaging Data Manager Digital Health - Spain - FSP

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 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.

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,

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.

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 captures (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 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.

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

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.

For an immediate interview, please contact marta.kuniewicz@parexel.com