AstraZeneca Pharmaceuticals LP Principal Programming Specialist in Gaithersburg, Maryland
At AstraZeneca every one of our employees makes a difference to patient lives every day. Each one of us believes that science has the ability to change lives and that to deliver this takes many people with many skill sets. When we deliver a life-changing medicine, that success comes from the combined efforts of all of our people.
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
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.