AD, Principal / Sr. AD, Sr. Principal Clinical Data Engineer

Description

Key contact partner in cultivating the "power of data" by means of (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. Subject Matter Expert (SME) internally in the clinical research development process through the provision of Leadership and advanced expertise in the areas of (i) data collection/curation, data review, delivery (ii) data standardization or (iii) process definition, testing and training. This position interprets scientific / clinical requirements to translate and document them into Company / Therapeutic Area level technical specifications for new substances, indications or marketing claims.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

AD 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.

SR AD Responsibilities

• Accountable/Responsible/Subject Matter Expert to interpret requirements to translate and document them into TA/Company level technical specifications. Provision 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 TA level operations of clinical data environments and respond to TA issues. Lead/develop processes/tools for data collection/curation, review, delivery/standardization.
• Subject Matter Expert (SME)/Process Lead, oversees the CDE tasks/processes performed by internal and external partners. Oversees CRO capacities/budget for outsourced trial/project tasks.
• Develop/test different ways to constantly improve data reliability, integrity and quality. Facilitates and ensures real-time inspection readiness of all data collection, data review/data delivery (DBL) deliverables for a trial/project and lead a team in/ 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.
• Identify trends in data science and in particular new data collection/curation/standardization/digital