AD, Principal Clinical Data Engineer

Boehringer Ingelheim is a global leader in the pharmaceutical industry, committed to the discovery and development of innovative products. They are seeking a Principal Clinical Data Engineer to oversee data collection, curation, and standardization processes for clinical trials, ensuring data quality and regulatory compliance.

Responsibilities:

• Accountable/Responsible to interpret requirements to translate and document them into project/TA level technical specifications. Provision 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
• Leads and oversees all CDE tasks performed by an external partner. Oversees CRO capacities/budget for outsourced trial/project tasks
• Develop/test different ways to constantly improve data reliability, integrity and quality. Ensures real-time inspection readiness of all data collection, data review/data delivery (DBL) deliverables for a trial/project and participates in regulatory agency and BI internal audits as necessary
• Collaborate with/influence members of the development team within BDS and with neighboring colleagues at BI on the project/product goals. Contributes 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 BI. Turn derived insights into new CDE approaches relevant for clinical development, registration, and marketing of drugs
• Conduct and support data collection/curation/standards process & tool trainings for Clinical Data Engineers
• Participate in or Lead cross-functional BI internal process development teams and drive/plan relevant CDE (data collection/curation/standardization) aspects. Participate in external working groups

Requirements:

• Bachelor's degree from an accredited institution, in Life Sciences, Computer Science, Software/Computer Engineering, or similar preferred, with many (greater than or equal to seven (>/= 7)) years of professional experience; Or
• Master's degree (e.g. MBA, MSc) from an accredited institution, in Life Sciences, Computer Science, Software/Computer Engineering, or similar preferred, with greater than or equal to three (3) years of professional experience
• Initial experience within the pharmaceutical industry, CROs or academic sites
• Leadership experience required
• Broad knowledge and advanced experience in understanding of clinical trial development process required
• In-depth knowledge and experience with the use of Data Collection Tools (EDC systems), Data Review Tools, and/or Data Standardization methods, requirements
• Thorough knowledge/experience in design of clinical trials, basic medical terminology and on processing clinical trial information
• Demonstrated ability to build/test, curate, oversee and interpret data in complex clinical trial and in projects with established BI experience
• Intellectual curiosity to find new and unusual ways solving data collection / curation / standardization / process definition, testing and training issues
• Excellent organizational skills, problem solving abilities, negotiation skills, time management skills and initiative required
• Strong communication skills: Confident and persuasive communicator to ensure that the message is clear and well understood
• Ability to work collaboratively on multi-disciplinary project teams and proactively manage relationships with external vendors required
• Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively
• Ability to lead and facilitate meetings required
• Ability to develop and deliver (technical) training required
• Language skills: English: fluent (Read/Write/Speak)
• Know, understand, and implement: International regulations and guidelines for good clinical and statistical practice from all ICH regions
• The various international guidelines on clinical development, data standardization, and BI processes and SOPs that govern clinical development in particular with respect to strategic areas (e.g. Clinical Development Plan)