Title : Clinical Reports Developer
Location: Fully Remote, Must be US based
Type: Contract
Pay Range: $45+/hr, commensurate with experience
Must be eligible to work for any employer in the US We cannot work with any other agency for this role If you are a Clinical Data Analyst in the pharmaceutical industry, interested in a remote contract opportunity with a sponsor company, apply today!
Job Description This individual will be responsible for creating and implementing study-specific data validation procedures and reports, managing the connection to varied data sources, and ensuring efficient scheduling, monitoring, and maintenance on the Clinical Data platform. The role requires identifying key data handling strategies, detailing requirements for scalable data management methods, and deriving study-specific monitoring and validation reports based on clinical protocols and amendments.
A typical day might include the following:
- Engage closely with Global Development business units such as Biostatistics & Data Management (BDM), Global Patient Safety, Precision Medicine, Pharmacometrics, Digital Health, etc. to deeply understand data quality, monitoring, and validation needs and transform these insights into detailed business requirements for clinical data products.
- Act as the primary point of accountability, responsibility, and expertise in interpreting Clinical Data business needs, meticulously translating and documenting these into comprehensive business specifications at the segment, modality, and company-wide levels.
- Demonstrate a business understanding of study-specific data to identify and assist in the successful application of consistent data management processes and documentation across assigned programs, ensuring consistency across data quality plans.
- Serve as the clinical data management lead and subject matter expert and the first escalation point for abstraction data ingestion, quality, modeling, and management issues.
- Thoroughly document the clinical product development process, including data sources, methodologies, algorithms, and underlying assumptions, to guarantee transparency, reproducibility, and auditability of clinical data products.
- Craft study-specific Data Quality specifications and define key Clinical data metrics to uphold the highest data quality and integrity standards across study lifecycles.
This Job Might Be for You If You:
- Have hands-on experience with various clinical datasets such as EDC and non-CRF data, combined with strong analytical abilities capable of managing diverse, large, and complex datasets, ranging from fundamental research collections to detailed clinical information.
- Possess a deep understanding of modern data analytic frameworks and technology, including expertise in Big Data structures, Lakehouse architectures, and contemporary techniques for data collection and amalgamation.
- Have practical experience with ETL processes, programming languages such as SQL, Python, R, and familiarity with AWS cloud infrastructure, including S3, Data Lake, along with the analytics realm.
To be considered for this role you must have:
- A bachelor’s degree in computer science, Data Science, Statistics, or a similar area is required.
- 7+ years of experience, specifically within clinical data analysis and preferably within the BioPharma sector.
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