Clinical Data Transformation Lead (Contract Remote)

 

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Clinical Data Transformation Lead to join one of our clients. 

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

SUMMARY
The role involves being a Clinical Data Transformation Lead in the Clinical Data Management area, focusing on enhancing data review and cleaning processes with innovative reports. It entails 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 detailing key da handling requirements for scalable data management methods, and deriving study-specific monitoring and validati reports based on clinical protocols and amendments. Ultimately, this position aims to advance clinical data management and informatics by improving data integrity, efficiency, and capacity for expansion.

RESPONSIBILITIES
• Engage closely with Global Development business units such as BDM, 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.
• 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.
• Prepare study-level reports within the Clinical Data Platform to support stakeholder activities and ensure the effective use of clinical study data.
• Query small to large clinical data sets, manage data ingestion and delivery specifications, and data modeling requirements. analyzes and evaluates clinical data, recognizes inconsistencies, and initiates the resolution of da problems.
• Design clear, concise requirements for clinical reports and dashboards, establishing relevant metrics to convey data-driven insights effectively. Present findings in a compelling manner, customized for key clinical business functions such as Clinical Data Management, Pharmacometrics,  etc.
• Work towards preparing Common Data Model mapping & transformations to ensure data is usable in the analytical layer/ and comply with the Governance Committee strategy.

QUALIFICATION

• Have a bachelor’s degree in computer science, Data Science, Statistics, or a similar area is required. Candidate should have substantial experience, ideally over 7 years, specifically within clinical data analysis and preferably within the BioPharma sector.
• Have hands-on experience with various clinical datasets such as EDC and non-crf dat 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. 
• Have full understanding of clinical trial process. 
• Have a passion for championing and implementing clinical data platform. 
• Should have practical experience with ETL processes, programming languages such a SQL, Python, R, and familiarity with the AWS cloud infrastructure, including S3,