This is a technical role with high leadership requirement position that will be responsible for initial set-up of the “Study Set-up Unit” of the Clinical Data Management Department for Data Management Operations, including establishing the infrastructure and programming environment, as well as DM related metrics.
This role will require Subject Matter Expertise in the area of “Study Set-up Unit” for Clinical Data Management, and frequent interactions with Senior Leadership and Key Stakeholders, including but not limited to Statistical programming, Statistician, IT, Medical, clinical Operations and the Data Management Leadership Team.
The goal assigned to the individual in this role will be to design, build, and implement the eco-system of the SSU to enable study to be initiated, conducted and closed out.
• Subject Matter Expert to provide leadership, guidance, and support with the development and management of clinical databases (Phase 1- 4) in the Pharmaceutical industry. (Prefer in using Veeva)
• Building of database structures / data entry forms using EDC (prefer Veeva) based on predefined study design specification
• Creation and maintenance of Global Library
• Programming of edit checks, derivations and custom functions
• Configuration Mapping for study integrations including: Safety Systems, Consolidated Clinical Views (CCVs), CTMS/EDC Configuration (prefer using Veeva).
• Troubleshoots issues with EDC (prefer Veeva), working with EDC (prefer Veeva), and IT as needed
• Serve as a primary technical point of contact for assigned studies & provide technical support during study execution and closure
• Support protocol amendments and database enhancements / migrations by:
o Making modifications/additions to database structures/data entry forms
o Modifying/adding necessary edit checks and derivations
o Updating any/all configuration mappings for study integrations that is impacted by the database changes
o Developing a Test Migration Plan and performing all necessary testing in the electronic CRF Amendment process in EDC, including creating the test migration plan, performing the impact analysis & reconciliation of changes the database structures, new and existing production data before deploying the changes into Production.
• Programming custom SAS Datasets from EDC data based on the specifications
• Lead the Development of external data transfers with multiple systems including: Merge, Trial Networks
• Create SAS/SQL Listing for Data Managers and assist them during data cleaning activities.
• Support the clinical data snapshot process & other database lock procedures.
• Generates and maintains all required documentation, including CRF Annotations, approval forms & supporting configuration reports, in support of database build and maintenance
• Helps ensure QC of deliverables related to study setup and maintenance in accordance with ICH-GCP, SOPs and company standards
• Promotes teamwork within study & functional teams, shares experiences and best practices
• Serve as a subject matter expert for study build/database development
• Has practical experience with various software tools and technologies such as but not limited to PL SQL, C#, SAS, Spotfire, JReview, MS Office Products, etc
• Knowledge of general clinical research and of the pharmaceutical industry.
May also Support or Provide Subject Matter Expertise to Clinical Programmers During Set-up or during Study Conduct Phase in the following Areas:
• Perform testing of components built in EDC; edit checks; migrations
• Set up of TSDV in EDC
• Automation of Manual checks from SAS datasets and EDC database
• Reporting - Visualization for:
o Medical review
o Local labs
o Operational dashboards
• Medical coding review reports
• Creation of Patient profile reports
• Any ad-hoc reporting requirements required for the study
• Interact with cross-functional team members during study build and Migrations
• Initiate cross-functional process improvements and create efficiencies within programming processes
• Train junior programmers in performing their activities
• 7+ years study database development experience in the pharmaceutical industry working with clinical trial data.
• Bachelor's degree, preferably in computing, engineering, or scientific discipline or equivalent experience
• Clinical trial knowledge is required.
• Veeva Study Builder with at least 2 years of hands-on experience building studies in Veeva.
• Experience or knowledge of Veeva EDC Safety Gateway, TSDV, Coder, Global Library is a plus.
• Thorough understanding of regulations (GCP, ICH Guidelines) and international standards (CDASH, SDTM) as they apply to creation and maintenance of clinical databases.
• Practical experience with programming using SAS, SQL, C#, SpotFire, Composite, and Python
• Excellent communication skills organized and ability to lead tasks from concept to delivery.
• Other programming languages e.g. S-PLUS, R, XML etc