Lead Data Engineer

Job Description

Activities may include, but are not limited to:

• Creates and develops clinical databases and data transfer files according to written specifications.
• Leads and participates 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 members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.
• Responsible for all data mapping deliverables including SDTM structure set-up and transformation maps to support multiple clinical programs.
• Creates and develops mapping specifications to meet SDTM structure requirements utilizing E2E visibility tools to ensure quality and timeliness of data flow.
• Leads and participates in developing transformation logic, and scripts to aid in the flow of data downstream for Analysis and Reporting.
• Responsible for reporting deliverables supporting data cleaning and verification and any external data captured in clinical studies.
• Coordinates data reporting activities for multiple clinical programs.
• Creates and reviews reporting specifications to ensure high quality deliverables, meet SDTM structure requirements and the needs of the business.
• Leads and participates in the review of standard and template reports, and scripts to aid in the review of data to ensure a quality database.
• Assumes the responsibilities for all database Archiving and Decommissioning activities in support of multiple clinical programs.
• Rendering of PDFs utilizing the approved tools via Electronic Data Capture for archiving data.
• Generation of Final Subject PDFs for site Archival package, and creation of the subjects needed for Item 12 submission requests.
• Decommissioning of trials from the production servers via AWS.
• Ensuring PDFs are filed in official repository (i.e., Veeva Vault) TMF.

Coordinates and participates in the following activities:

• Develop required training and provide ongoing training and development to Developers on standards and Study Build, transformations, mapping, reporting and Archival Process.
• Interfaces with functional manager to assure consistency of technical and process strategies across all therapy areas.
• Plans appropriately to ensure adherence to timelines.
• Acts as a technical resource to a functional group.
• Interface with members of study teams and key stakeholders, to integrate requirements into all deliverables.
• Ensures adherence to clinical database standards, SDTM structures, SOPs, and Process Guidelines.
• Trains new hires and participates in the interview process.
• Helps to develop a customer oriented and can-do attitude on a team and contributes as subject matter expert for trouble-shooting findings.
• Leads and participates in activities including, but not limited to, task forces, testing of new systems and helps coordinate technical initiatives.
• Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of a group.
• Assist Manager/Associate Director in project planning, manpower projections and resource allocations across therapy areas.

B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant skills and experience.

• Knowledge of database structures and available tools to manage, extract, report, and warehouse data.
• Minimum 4 years of database development or data programming experience, at least three of which including clinical databases.
• Demonstrated strong technical proficiency in a Clinical Data Management Systems (i.e., InForm, Inform Architect, Central Designer, SQL-PL/SQL
• Minimum 4 years of experience with
  CDISC Standards, (SDTM, CDASH, Define.xml)
  XML, Java
  ELT tools
• 3+ years’ experience in data transformations and data loading in tools such as InForm
• 2+ years’ experience in System Development Lifecycle Management / system validation knowledge.
• 3+ years’ experience with reporting tools such as Cognos or JReview.
• Experience in eCRF generation for site documentation and downstream regulatory compliance deliverables.
• Advanced knowledge of the Data Management process from study start-up through close-out.
• Ability to collaborate and communicate with cross functional stakeholders to interpret and ensure quality report specifications and input to report development.
• Solid knowledge of MS Windows/Office software and exposure to web-based applications.
• Effective communication skills (oral and written) with the ability to communicate with both the technical and business areas.
• Strong organizational and critical thinking skills.
• Keen sense of urgency and customer focus.
• Ability to work cross functionally and as part of a team.
• Able to work independently, under pressure and change environment with flexibility.
• 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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