Description

Associate Director, Principal Clinical Data Engineer at Boehringer Ingelheim Pharmaceuticals, Inc. in Ridgefield, CT (Telecommuting permitted: work may be performed within normal commuting distance from this office 70% of the time)

Job Duties: Key contact partner in (i) data collection/curation, data review, data delivery, (ii) data standardization or (iii) process definition, testing and training. Translate the science into technical specifications. Collect, ingest, structure, curate and standardize all kinds of Clinical Trial related data from internal and external sources. Ensure Data Quality and Integrity by implementing plausibility checks, anomaly detection, and fraud detection methods in data collection systems. Support the clinical research development process through the provision of advanced expertise in the areas of (i) data collection/curation, data review, data delivery, (ii) data standardization or (iii) process definition, testing and training. Interpret scientific/clinical requirements to translate and document them into Therapeutic Area (TA) / Project level technical specifications for new substances, indications or marketing claims. Provide clinical project / TA level data to business consumers. Facilitate requirements gathering from consumers and develop global solutions to meet immediate and long-term needs of the business. Monitor and maintain ongoing project / TA level operations of clinical data environments, and respond to project / TA issues. Lead and oversee all clinical data engineering (CDE) tasks performed by an external partner. Oversee CRO capacities / budget for outsourced trial / project tasks. Develop/test different ways to constantly improve data reliability, integrity and quality. Ensure real-time inspection readiness of all data collection, data review/data delivery (DBL) deliverables for a trial/project and participate in regulatory agency and company internal audits as necessary. Collaborate with/influence members of the development team within Biostatistics and Data Sciences (BDS) and with neighboring colleagues at the company on the project/product goals. Contribute to cross-functional and team-based thinking. Keep abreast of data science and in particular new data collection/curation/standardization/digital tech solutions and innovative processes/tools within and outside the company. Turn derived insights into new CDE approaches relevant for clinical development, registration, and marketing of drugs. Conduct and support data collection/curation/standards process and tool trainings for Clinical Data Engineers. Participate in or lead cross-functional company internal process development teams and drive/plan relevant CDE (data collection/curation/standardization) aspects. Participate in external working groups. *Telecommuting permitted: work may be performed within normal commuting distance from the Boehringer Ingelheim Pharmaceuticals, Inc. office in Ridgefield, CT 70% of the time.

Work Schedule: 40 hours per week (8:00am to 5:00pm)

Description (cont'd)

Job Requirements: Bachelor's degree (U.S. or foreign equivalent) in Pharmaceutical Technology, Biomedical Technology, Computer Science, Software Engineering, Computer Engineering, or a related field and seven (7) years of experience in the job offered or in a related role OR Master's degree (U.S. or foreign equivalent) in Pharmaceutical Technology, Biomedical Technology, Computer Science, Software Engineering, Computer Engineering, or a related field and three (3) years of experience in the job offered or in a related role. Must have three (3) years of experience with: Implementing (i) international regulations and guidelines for good clinical and statistical practice from International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, (ii) international guidelines on clinical development and data standardization, and (iii) processes and Standard Operating Procedures that govern clinical development; Working with Data Collection Tools, Data Review Tools, and Data Standardization methods and requirements; Design of clinical trials, basic medical terminology, and processing of clinical trial information; Working collaboratively on multi-disciplinary project teams and managing relationships with external vendors; Leading end-to-end clinical data management activities, including database specification, build, trial conduct and closeout, using an electronic data capture system; Project Management and Agile methods; and, Maintaining Clinical Data Management related study documents, including Data Management Plan, Data Validation Plans, Data Review Plan, and Electronic Case Report Form Completion Guidelines, to ensure data quality and data standardization. 10% domestic and international travel required.