AD, Principal Clinical Data Engineer

Duties & 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.
• 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;
• 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)

Compensation

This position offers a base salary typically between $140,000 and $222,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.