Contract Clinical Rptg Dev

Date Posted: 9/5/2024

Contract Clinical Reporting Developer
Remote, NY

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.

Description:
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. Demonstrates a business understanding of study specific data to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i.e., 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.

Required:
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, which ranges from fundamental research collections to detailed clinical information. Possess a deep understanding of modern data analytic frameworks and technology, which includes expertise in Big Data structures, Lakehouse architectures, as well as contemporary techniques for data collection and amalgamation. Should have practical experience with ETL processes, programming languages such as SQL, Python, R, and familiarity with the AWS cloud infrastructure, including S3, Data Lake, along with analytics realm. Have a bachelor’s degree in computer science, Data Science, Statistics, or a similar area is required. Candidates should have 7+ years of experience, specifically within clinical data analysis and preferably within the BioPharma sector.

Please contact Darren Gutowski at dgutowski@clarkdavis.com