THE POSITION The exact job title is (Senior) Clinical Data Engineer with focus on Clinical Data Management.
Biostatistics and Data Sciences (BDS) is a global organization with more than 400 employees within the Human Pharma Business Unit. Working in close collaboration with other functions at Boehringer Ingelheim (BI) and external vendors we combine methodological and technical data science skills with business and scientific expertise to drive smart, timely and confident decision making at every stage of drug development, approval and access.
On our journey to transform BDS into a modern data science organization in clinical development capable to thrive in a world of rapid and continuous change, we have changed our working model towards an operating model with emphasis on cross-functional and self-organized teams creating customer-validated value. This also will be supported by development teams focusing on optimization of processes and best use of systems in the capability management area.
As a Clinical Data Manager / Clinical Data Engineer you are the key contact partner in cultivating the "power of data" by means of data collection/curation, data review, delivery and data standardization. You will be an active member of a BDS development team.
This position can be filled in Ingelheim or Biberach.
Tasks & responsibilities - You will be responsible (and accountable in the Senior role) for the delivery of quality data of our clinical trials for informed decision making to get our drugs to patients faster. You serve as a key liaison to establish, align, and confirm data management activities for assigned trial(s), requiring regular interaction with other internal and external partners. Your duties in detail:
- Review clinical trial protocols and identify requirements for proper data capture.
- Define the eCRF, specify the clinical trial database, including UAT and development of edit check specifications.
- Define or review creation and maintenance of all essential TMF documentation including but not limited to: CRF specifications, eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plan, Data Transfer Agreements and Data Review Plan.
- Creation and execution of data quality checks throughout study conduct.
- Provision of adequate sponsor oversight of data management CROs or external data providers, ensuring the overall trial data quality is fit for purpose, including regulatory compliance.
- Specify, integrate and reconcile external data (non-CRF data including but not limited to: digital data, ePRO, bioanalytical data) from vendors or other internal departments into the clinical trial database.
- Ensuring the delivery of SDTM (Study Data Tabulation Model) compliant data for analyses.
- Assessment of Pinnacle 21 Enterprise outputs, including identification and initiation of corresponding action.
- Present and train at CRA / Investigator meetings.
- Attend and contribute to trial oversight meetings (TOM) and other trial team meetings as needed.
- Collaborate with the trial team to ensure that the database can be closed and locked according to the planned timelines and defined quality.
- Understanding and complying with the principles of ICH GCP guidelines, global regulatory requirements, and industry standards applicable to data capture and data management process.
Additional tasks & responsibilities for the Senior role:
- Onboarding of new colleagues.
- Participation in regulatory agency and BI internal audits as necessary.
- Share knowledge and conduct trainings within the Clinical Data Engineering community
Requirements - Bachelor's/ Master's degree (e.g. MBA, MSc) in Life Sciences, Computer Science, Software/Computer Engineering, or related. Or high-qualified/multifaceted professional qualifications with relevant professional experience
- Understanding of dependencies among interfaces
- Experience in working in/with agile teams and/or as a product owner is a plus
- Knowledge in and experience with the use of Data Collection Tools (EDC systems), Data Review Tools (e.g. JReview), and/or Data
- Standardization methods and requirements is a plus
- Understanding of CDISC standards (CDASH, SDTM, etc....) is a plus
- Technical expertise and / or programming skills (preferably SAS) is a plus
- Good organizational skills, problem-solving abilities, time management skills and taking initiative
- Excellent communication skills and fluency in English in speaking and writing
Additional requirements for the Senior role:
- Several years of experience in clinical development, especially in Clinical Data Management
- You are responsible for offering guidance to junior colleagues, act