As a Rave Database Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
• Analyze data and content from external data streams and propose efficient pathways to integrate relevant data into clinical data repository to support analysis, reporting and submission of data.
• Liaise with key data stakeholders to understand the purpose of data collection and agree upon data availability and consumption requirements.
• Liaise with external data providers, Data Managers and Clinical Programmers to drive optimal data transfer, ingestion, transformation and storage solutions.
• Oversee the development of data transfer agreements
• Take the lead in developing data transfer agreements for new data stream types or for data streams with need for understanding complex data structures and/or content.
• Define data collection metadata for eSource data streams in a Metadata Repository; Ensure end to end oversight on full data flow; Identify downstream impact of data collection metadata deviations from standards.
• Identify and resolve issues that may negatively impact study timelines. Escalate to leadership as needed.
• Develop procedural documents, job aids and training material as part of a compliant environment
• Lead or participate in cross-functional improvement initiatives to develop an industry leading data acquisition capability.
• Keep abreast of relevant industry trends and innovative technologies related to eSource
• Actively contribute to the shaping and implementation of the Data Acquisition strategy, improving re-usability, efficiency and consistency of data acquisition tools across studies and therapeutic areas
You are:
• BS/BA degree or higher in Health Sciences or equivalent work experience is required. PhD preferred.
• Relevant experience within the Pharmaceutical, CRO or Biotech industry is required, see below for details
• Good understanding of overall drug development process with proven expertise in clinical trial setup and execution
• Experience with collecting Safety Lab, PK, Biomarkers, ECG, eCOA/ePRO or other external data ingestion within clinical trials is preferred
• Experience with collecting data from Digital Health technologies and/or RWD are assets
• Deep expertise in specialized data streams (omics data, flow cytometry, …) is an asset
• Strong knowledge of GCP/ICH guidelines
• In dept knowledge of data collection and submission industry standards (CDASH, SDTM) is required
• Ability to work in a global setting across different cultures within a matrix environment
• Demonstrated experience in working with external data providers within a clinical study setting
• Strong project management knowledge (defining objectives and deliverables, managing a cross-functional project team, managing stakeholders, negotiating, leading with influencing)
• Excellent verbal and written communication skills
• Effectively cope with change (ability to deal with ambiguity, shift gears comfortably, decide and act without having the total picture, and handle risk and uncertainty)
• Ability to think out of the box with creative and innovative mindset
• A team player, able to motivate and empower others
• Working knowledge of industry leading eCRF tools (Rave) is preferred
• Knowledge of EHR to EDC middleware technologies (Clinical Pipe, …) or health care data exchange formats (HL7 FHIR, …) are assets
• Experience working with a clinical metadata repository and understanding of end-to-end clinical metadata concepts are assets
(Minimum of 5 years of DM experiences & mid-level relevant skills)
What ICON can offer you:
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