As the Principal Programming Specialist within Global Medicines Development (GMD) you act as the technical leader or subject matter expert for the department, therapeutic area, or drug project. Reporting to the Senior Director of Global Data Management you will lead and direct elements of the department, Therapeutic area, or project work with accountability for the quality of elements of project programming work worldwide.
If you're inspired by the possibilities of science to make a difference and ready to discover what you can do - join us.
- Subject Matter Expert to provide leadership, guidance, and support with the development and management of clinical databases (Phase 1- 4) in the Pharmaceutical industry using Medidata Rave
- Building of database structures / data entry forms using Medidata Rave based on predefined study design specification
- Creation and maintenance of Global Library
- Programming of edit checks, derivations and custom functions (Rave Custom Scripts - C#)
- Configuration Mapping for study integrations including: Safety Systems, Consolidated Clinical Views (CCVs), CTMS/Rave Configuration.
- Troubleshoots issues with Medidata, working with Medidata 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:
- Making modifications/additions to database structures/data entry forms
- Modifying/adding necessary edit checks and derivations
- Updating any/all configuration mappings for study integrations that is impacted by the database changes
- Developing a Test Migration Plan and performing all necessary testing in the electronic CRF Amendment process in Rave, 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 RAVE - eCRF; edit checks; migrations
- Set up of TSDV in Rave
- Automation of Manual checks from SAS datasets and Rave database
- Reporting - Visualization for: medical Review, local labs, and 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 required, preferably in computing, engineering, or scientific discipline or equivalent experience
- Clinical trial knowledge is required
- Medidata Rave Study Builder certification with at least 5 years of hands-on experience building studies in Rave
- Experience or knowledge of Rave Safety Gateway, TSDV, Medidata 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, RAVE, RAVE Reports, C#, SpotFire, Composite, Rave Web Services, and Python
- Excellent communication skills, organized and ability to lead tasks from concept to delivery