Clinical Data Manager - Engineer

Boehringer Ingelheim is a global leader in the pharmaceutical industry, and they are seeking a Clinical Data Manager - Engineer to enhance their data collection and management processes. The role involves interpreting scientific requirements into technical specifications, ensuring data quality, and collaborating with cross-functional teams to support clinical research development.

Responsibilities:

• Accountable/responsible to interpret requirements to translate and document them into trial level technical specifications. Provision clinical trial data to business consumers. Facilitate requirements gathering from consumers and develop solutions to meet immediate and long-term needs of the business. Monitor and maintain ongoing trial level operations of clinical data environments and respond to trial issues
• Responsible for oversight of: Data collection/curation, data review, delivery or Data standardization or Process definition, testing and training tasks within a trial performed by a BPO/CRO
• Identify and recommend 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 and supports regulatory agency and BI internal audits as necessary
• Collaborate with 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

Requirements:

• Experience in understanding of clinical trial development process required
• Initial experience within the pharmaceutical industry, CROs or academic sites
• Knowledge in and experience with the use of Data Collection Tools (EDC systems), Data Review Tools, and/or Data Standardization methods, requirements
• Knowledge/experience in design of clinical trials, basic medical terminology and on processing clinical trial information
• No leadership experience required
• Demonstrates some knowledge in data collection/curation, data review, delivery /data standardization / process definition, testing and training methods
• Excellent organizational skills, problem solving abilities, negotiation skills, time management skills and initiative required
• Good written and oral communication skills in the English language required
• 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
• 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)
• Bachelor's degree from an accredited institution, in Life Sciences, Computer Science, or similar area preferred, with a minimum of three (3) years of experience required. (DE: Can be replaced by high-quality/multifaceted professional qualifications with relevant professional experience)