Senior Clinical Data Engineer

2 months ago

Ridgefield, United States Boehringer Ingelheim Full time

Senior Clinical Data Engineer
BI Pharmaceuticals, Inc. - Ridgefield, CT
Senior Clinical Data Engineer at Boehringer Ingelheim Pharmaceuticals, Inc. in Ridgefield, CT (Telecommuting permitted: Work may be performed within normal commuting distance from this office 60% of the time).

Job Duties : Serve as a key liaison / Clinical Data Management (CDM) lead to establish, align, and confirm data management expectations for assigned trial(s), requiring regular interaction with other internal and external partners. Review clinical trial protocols and identify requirements for proper data capture. Oversee the design, creation and UAT Plan of the clinical trial database along with development of edit check specifications and manual data review listings. Define or review creation and maintenance of all essential data management documentation including CRF specifications, eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plan (detailing complete data management processes throughout clinical studies), Data Transfer Agreements and Data Review Plans, in accordance with the protocol, BI and project data standards as applicable. Integrate and reconcile external data (non-CRF data) from vendors or other internal departments into the clinical trial database. Initiate and complete Trial Master File (TMF) real time with relevant documentation containing the necessary CDM / Biostatistics & Data Sciences (BDS) documentation for a trial. Establish conventions and quality expectations for clinical trial data and plan and track the content, format, completeness, quality, and timeliness of the trial data collection process and other CDM deliverables via data analytics throughout the conduct of a trial. Collaborate with the trial team to ensure that the database can be closed and locked according to the planned timelines and defined quality. Responsible for the database lock process and accountable for the integrity of the data collected. Ensure that SDTM (Study Data Tabulation Model) compliant data is available for analyses. Attend trial oversight meetings (TOM) and other trial team meetings as needed. Present and train at CRA / Investigator meetings. Participate in regulatory agency and BI internal audits as necessary. Identify and participate in CDM related improvement processes, e.g. system and tool improvement initiatives within CDM/BDS. Keep informed of data science and in particular new data collection /curation /standardization / digital tech solutions and innovative processes/tools within and outside BI. *Telecommuting permitted: Work may be performed within normal commuting distance from the Boehringer Ingelheim Pharmaceuticals, Inc. office in Ridgefield, CT 60% of the time. **Multiple openings.

Work Schedule : 40 hours per week (8:00am to 5:00pm)

Description (Cont'd)
Job Requirements : Master’s degree (US or foreign equivalent) in Life Sciences, Regulatory Affairs, Computer Science, Informatics, Health Informatics, or a related field and three (3) years of experience in the job offered or in a related role OR Bachelor’s degree (US or foreign equivalent) in Life Sciences, Regulatory Affairs, Computer Science, Informatics, Health Informatics, or a related field and five (5) years of experience in the job offered or in a related role. Must have experience with: leading end-to-end clinical data management activities (including database specification, trial conduct and closeout) using an electronic data capture (EDC) system; transforming data requirements of the clinical trial protocol into EDC data collection case report forms in compliance with CDISC (SDTM) standards; transforming external data requirements of the clinical trial protocol into Data Transfer Agreements (DTAs); creating EDC data validation (cleaning) specifications; creating manual data review listings and tables in tools such as JReview or SAS to ensure quality data for the trial; participating in Trial Oversight Meetings with cross functional study team members to ensure on-going review of trial conduct and data quality; serving as the primary point of contact for CRO oversight for database building, data cleaning, query management, or SDTM transformation; ensuring the overall trial data quality is fit for purpose, including Regulatory (SDTM) compliance; maintaining Clinical Data Management (CDM) related study documents including Data Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure data quality and data standardization; Project Management and Agile methods; providing recommendations to implement new technologies resulting in process improvements; understanding coding dictionaries such as MedDRA and WHODrug; understanding and complying with the principles of ICH GCP guidelines, global regulatory requirements, and industry standards applicable to data capture and the data management process; and working with MS Office Suite (Excel, Word, and PowerPoint), EDC tools such as Medidata RAVE, and data review tools such as SAS and JReview.

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