Senior EDC Programmer – External Data Specialist
Location: Full-Time, Remote-Based in the United States or Canada
Why IQVIA
Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with fully dedicated resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading CRO while operating within a sponsor environment and utilizing sponsor systems. Being part of DSSS means being part of a passionate team dedicated to advancing medicine and reshaping healthcare. Your role will be both challenging and rewarding, making a real impact.
Experience the best of both worlds and become a core part of our dynamic team today!
Additional Benefits:
- Home-based remote work opportunities
- Great work/life balance
- Collaborate on projects and innovations with industry leaders in the Pharma and CRO sectors
- Cohesive team environment fostering a collaborative approach to study work
- Variety of therapeutic areas, indications and, study phases
- Job stability; long-term engagements and development opportunities
- Career advancement opportunities
Responsibilities:
- Execute deliverables for Standardized External Data Streams.
- Assess external data collection requirements per protocol and planning of external data stream set-up activities and related deliverables to meet study start-up timelines.
- Liaise with key data stakeholders to establish the purpose of data collection and requirements for the transfer, ingestion, and structure of data for each data stream in compliance with applicable data protection laws and regulations, utilizing available standards and templates.
- Create change requests for the definition of new test concepts or data structures relating to external data.
- Develop trial-specific Data Transfer Agreements (tsDTA’s) accurately documenting study requirements and methods for the data transfer, ingestion, and structure. Ensure data transfer frequencies are sufficient for the agreed requirements (medical data review, central monitoring, and reporting and analysis).
- Liaise with external data providers to ensure alignment and agreement of tsDTA.
- Translate medical and scientific concepts into data mapping guidance, per agreed data model and documented in the annotated Data Transfer Agreement
- UAT of test data transfers ensure accuracy and consistency with data specifications defined in Data Transfer Agreements.
- Implement data transfer mechanisms for external data streams (into CDR) including access for external data providers.
- Monitor availability and accuracy of external data streams, liaise with external data providers to resolve data transfer issues relating to conformance of data.
- Execute deliverables for complex novel External Data Streams.
- Coordinate external data stream set-up activities ensuring quality and delivery to agreed timelines, identifying, and managing risks in collaboration with Global Data Manager.
- Ensure external data stream set-up activities are conducted and optimized according to the latest standards and best practices.
- Ensure consistency of external data stream set-up across studies within a program.
- Provide external data stream subject matter expertise for complex external data streams.
- Provide training for External Data Stream processes.
- Identify and communicate lessons learned and best practices to trial level teams within program.
- Participate in process, system, and tool improvement initiatives within clinical data management.
Education and Experience:
- Bachelor’s degree in life science or related field and/or 5+ years’ hands-on experience working within a Pharmaceutical or Clinical Research Organization
- Experience integrating and managing data sources such as HL7, FHIR, and EMRs to integrate into Medidata Rave required
- Knowledge of tsDTA, tSDV, and JSON files strongly preferred
- Excellent verbal and written communication skills and highly effective interpersonal, and organizational skills
- Oncology experience strongly preferred but not required
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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
The potential base pay range for this role, when annualized, is $106,200.00 - $218,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.