Job Information
Boehringer Ingelheim Senior Principal, Clinical Data Engineering (Data Management) in Ridgefield, Connecticut
Description
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 several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Senior Associate Director, Clinical Data Engineering is the key contact partner in cultivating the "power of data" by means of data collection/curation, data review, delivery data standardization or process definition, testing and training. Translate the science into technical specifications. This role will collect, ingest, structure, curate and standardize all kinds of Clinical Trial related data from internal and external sources as well as ensure Data Quality and Integrity by implementing plausibility checks, anomaly detection, and fraud detection methods in data collection systems. This is a global role which may have direct reporting within the local organization.
The SR AD, Clinical Data Engineering is a Subject Matter Expert (SME) internally in the clinical research development process through the provision of Leadership and advanced expertise in the areas of data collection/curation, data review, delivery data standardization or process definition, testing and training. This position interprets scientific/clinical requirements to translate and document them into Company / segments/modalities level technical specifications for new substances, indications or marketing claims.
As Head of AH Clinical Data Engineering (CDE) the incumbent is accountable to define the strategy for CDE initiatives while following the guardrails of the global strategy which is provided by the Group Head (e.g., Head of Clinical, or Head of BDS). This role drives strategic decisions, cross-functional alignment, and integrator of the deliverables into CDE.
Duties & Responsibilities
Accountable/Responsible/Subject Matter Expert to interpret requirements to translate and document them into segment/modality/Company level technical specifications.
Provision segment/modality level data to business consumers.
Facilitates requirements gathering from consumers and develop global solutions to meet immediate and long-term needs of the business.
Monitors and maintains ongoing segment/modality level operations of clinical data environments and respond to issues.
Leads /develops processes/tools for data collection/curation, review, delivery/ standardization.
Oversees the CDE tasks/processes performed by internal and external partners.
Oversees CRO capacities/budget for outsourced trial/project tasks.
Develops/tests 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 deliverables for a trial/project and leads a team in / participates in regulatory agency and BI internal audits as necessary.
Collaborates 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.
Identifies trends in data science and in particular new data collection/curation/standardization/digital tech solutions and innovative processes/tools within and outside BI.
Initiates and turns derived insights into new CDE approaches relevant for clinical development, registration, and marketing of drugs.
Plans/Designs and Conducts data collection/curation/standards process & tool trainings for Clinical Data Engineers.
Leads/Participates in cross-functional BI internal process development teams and drives/plans relevant CDE (data collection/curation/standardization) aspects.
Participates in external working groups.
Requirements
Bachelor’s degree or Master’s degree (e.g., MBA, MSc); Major / Focus: Life Sciences, Computer Science, Software/Computer Engineering, or similar preferred.
Minimum of five (5) years’ experience in a related field is required.
Advanced understanding of cutting-edge use of Data Collection Tools (EDC systems), Data Review Tools, and/or Data Standardization methods, requirements.
Excellent knowledge/experience in design of clinical trials, basic medical terminology and on processing clinical trial information.
Excellent organizational skills, problem solving abilities, negotiation skills, time management skills and initiative required.
Excellent, demonstrated 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.
Experience running project with agile methods preferred.
Language skills – English: fluent (Read/Write/Speak).
Eligibility Requirements :
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
Compensation
This position offers a base salary typically between $135,000 and $232,000. 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. (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards)
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.