#R-006836
Job Function:
Data Analytics & Computational Sciences
Job Sub Function:
Clinical Data Management
Job Category:
Professional
All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom
Job Description:
Are you ready to join a growing team driving the implementation of data acquisition strategy and the future e-clinical trial landscape at Johnson & Johnson?!
As a key member of the eSource Data Acquisition team, the Analyst II Esource Data Acquisition Expert uses in-depth knowledge of eCRF build for eSource capability, data collection, ingestion, transformation, and storage of external data to support a diverse clinical development portfolio.
You will be empowered to drive data acquisition activities for a portfolio of trials and data streams within assigned scope on a variety of domains (e.g., non-CRF, Devices & Apps, Electronic Health Records (EHR), Direct Data Capture).
The successful candidate will work in an emerging, agile, fast-paced, highly motivated, team centric and evolving data environment. You will apply creative problem-solving skills and knowledge to support R&D innovation, staying abreast of relevant industry trends and innovative technologies related to external data.
Key responsibilities
• Collaborate cross-functionally and with sites and external data providers to understand the purpose of data collected, align data availability and consumption requirements, and drive optimal data acquisition solutions.
• Analyze data and content from external data streams and consult on the eCRF or other sponsor systems build to propose efficient pathways to acquire and integrate relevant data.
• Lead the development and setup of traditional and novel data streams and related documents within assigned scope.
• Participate in continuous improvement initiatives contributing to innovation and the maturation of an industry leading data acquisition capability.
• Actively contribute to the shaping of the organization, improving re-usability, efficiency, and consistency of tools and processes across studies and therapeutic areas.
Qualifications, skills, and experience
Required:
• Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences.
• Minimum 2 years of experience in Pharmaceutical, Healthcare, CRO or Biotech industry or related field or industry.
• Experience working in a multi-functional environment and ability to adapt to different ways of working.
• Proven track record of effective communication skills, including strong verbal and written communication, influencing, and partnering skills.
• Demonstrated experience working with external data providers, clinical data, and data structures within a clinical study/research setting.
• Good understanding of the overall drug development process and GCP/ICH guidelines.
Preferred:
• Demonstrated understanding of relevant data collection, transfer, and submission industry standards (e.g., HL7 FHIR, SDTM, ODM).
• Experience working with data from EHR/EMR, Digital Health technologies, and/or Real-World Data.
• Experience in specialized data streams (e.g., 'omics data, immunogenicity, flow cytometry, PK, biomarkers).