Lead Data Engineer
hace 7 días
We are seeking a highly skilled Lead Data Engineer to join our team at Merck Gruppe - MSD Sharp & Dohme. As a key member of our Clinical Data Management team, you will be responsible for leading the development and maintenance of clinical databases and data transfer files.
Key Responsibilities- Database Development: Create and develop clinical databases and data transfer files according to written specifications.
- Leadership and Collaboration: Lead and participate in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS).
- Interface with Study Teams: Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.
- Data Mapping: Responsible for all data mapping deliverables including SDTM structure set-up and transformation maps to support multiple clinical programs.
- Mapping Specifications: Creates and develops mapping specifications to meet SDTM structure requirements utilizing E2E visibility tools to ensure quality and timeliness of data flow.
- Transformation Logic: Leads and participates in developing transformation logic, and scripts to aid in the flow of data downstream for Analysis and Reporting.
- Data Reporting: Responsible for reporting deliverables supporting data cleaning and verification and any external data captured in clinical studies.
- Coordination: Coordinates data reporting activities for multiple clinical programs.
- Reporting Specifications: Creates and reviews reporting specifications to ensure high quality deliverables, meet SDTM structure requirements and the needs of the business.
- Database Archiving and Decommissioning: Assumes the responsibilities for all database Archiving and Decommissioning activities in support of multiple clinical programs.
- PDF Generation: Rendering of PDFs utilizing the approved tools via Electronic Data Capture for archiving data.
- Final Subject PDFs: Generation of Final Subject PDFs for site Archival package, and creation of the subjects needed for Item 12 submission requests.
- Decommissioning: Decommissioning of trials from the production servers via AWS.
- PDF Filing: Ensuring PDFs are filed in official repository (i.e., Veeva Vault) TMF.
- Education: B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant skills and experience.
- Experience: Minimum 4 years of database development or data programming experience, at least three of which including clinical databases.
- Technical Skills: Demonstrated strong technical proficiency in a Clinical Data Management Systems (i.e., InForm, Inform Architect, Central Designer, SQL-PL/SQL).
- CDISC Standards: Minimum 4 years of experience with CDISC Standards, (SDTM, CDASH, ), XML, Java, ELT tools.
- Data Transformations: 3+ years' experience in data transformations and data loading in tools such as InForm.
- System Development Lifecycle Management: 2+ years' experience in System Development Lifecycle Management / system validation knowledge.
- Reporting Tools: 3+ years' experience with reporting tools such as Cognos or JReview.
- eCRF Generation: Experience in eCRF generation for site documentation and downstream regulatory compliance deliverables.
- Data Management Process: Advanced knowledge of the Data Management process from study start-up through close-out.
- Communication Skills: Ability to collaborate and communicate with cross functional stakeholders to interpret and ensure quality report specifications and input to report development.
- Organizational Skills: Strong organizational and critical thinking skills.
- Urgency and Customer Focus: Keen sense of urgency and customer focus.
- Teamwork: Ability to work cross functionally and as part of a team.
- Independence: Able to work independently, under pressure and change environment with flexibility.
- Regulatory Knowledge: An overall working knowledge of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database validation and documentation processes, and 21 CFR Part 11.
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