Clinical Reports Developer / Clinical Data Management Lead

100% remote role

Clinical Reports Developer / Clinical Data Management Lead

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. This is a newly created role, designed for someone with a strong understanding of clinical data. The ideal candidate should have a deep knowledge of why and how data is collected, particularly in relation to EDC forms and third-party data. They will be responsible for preparing comprehensive patient reports, such as PK (pharmacokinetic) data reports, and ensuring data quality throughout the process. This role will involve managing data ingestion, using SQL and Python to generate reports, and identifying any issues with datasets to communicate to the technical team. The individual will interface with the Pharmacometrics and Data Management teams.

Responsibilities:

• 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.

Key Requirements:

• Must be able to write complex SQL and Python code.
• A solid understanding of clinical data is essential.
• The role is highly visible, excellent communication skills a must
• The candidate will be involved in coding as part of their day-to-day responsibilities.

Experience:

• 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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.