Principal / Senior Clinical Data Engineer (SDTM - Data Management)

1 month ago

Ridgefield, United States Boehringer Ingelheim Full time
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. Supports the clinical research development process through the provision of 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 Project/Trial 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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.Duties & Responsibilities
  • Accountable/Responsible to interpret requirements to translate and document them into trial / project level technical specifications. Provision clinical trial/project 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/project level operations of clinical data environments and respond to trial/project issues.
  • Accountable/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
  • Recommend/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 and participates in 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.
  • Conduct and support data collection/curation/standards process & tool trainings for Clinical Data Engineers.
  • Participate in cross-functional BI internal process development teams and drive/plan relevant CDE (data collection/curation/standardization) aspects.
Requirements

Senior, CDE Requirements

  • Bachelor's degree from an accredited institution, in Life Sciences, Computer Science, Software/Computer Engineering, or similar preferred. Initial experience within the pharmaceutical industry, CROs or academic sites: several (greater than or equal to five (>/= 5) years of professional experience. (DE: Can be replaced by high-quality/multifaceted professional qualifications with relevant professional experience); Or
  • Master's degree (e.g. MBA, MSc) from an accredited institution. Initial experience within the pharmaceutical industry, CROs or academic sites: three (3) years of professional experience.
  • Advanced experience in understanding of clinical trial development process required.
  • High proficiency in SDTM, highly preferred

Principal, CDE Requirements:

  • Bachelor's degree from an accredited institution, in Life Sciences, Computer Science, Software/Computer Engineering, or similar preferred. Initial experience within the pharmaceutical industry, CROs or academic sites: several (greater than or equal to seven (>/= 7) years of professional experience. Or
  • Master's degree (e.g. MBA, MSc) from an accredited institution. Initial experience within the pharmaceutical industry, CROs or academic sites: three (3) years of professional experience.
  • Advanced experience in understanding of clinical trial development process required.
  • High proficiency in SDTM, highly preferred

Additional Requirements:

  • Demonstrated ability to build/test, curate, oversee and interpret data in routine clinical trials.
  • Intellectual curiosity to find new and unusual ways solving data collection / curation / standardization / process definition, testing and training issues.
  • Basic leadership experience required.
  • Sound knowledge and experience with the use of Data Collection Tools (EDC systems), Data Review Tools, and/or Data Standardization methods, requirements.
  • Sound 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.
  • 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.
  • 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

The Senior position offers a base salary typically between $111,000 and $183,000 and the Principal 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.PDN-9bc6b3c2-6f3f-4a33-a4a0-33d15f5b9a93

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