Senior EDC External Data Specialist, eSource

Senior EDC Programmer External Data Specialist

Location: FullTime RemoteBased 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:

• Homebased 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; longterm 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 setup activities and related deliverables to meet study startup 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 trialspecific Data Transfer Agreements (tsDTAs) 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 setup activities ensuring quality and delivery to agreed timelines identifying and managing risks in collaboration with Global Data Manager.
• Ensure external data stream setup activities are conducted and optimized according to the latest standards and best practices.
• Ensure consistency of external data stream setup 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:

• Bachelors degree in life science or related field and/or 5 years handson 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 filesstrongly 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

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. potential base pay range for this role when annualized is $106200.00 $218000.00. The actual base pay offered may vary based on a number of factors including jobrelated qualifications such as knowledge skills education and experience; location; and/or schedule (full or parttime). 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.