Data Management Reporting Programmer - Remote - Contractor
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Data Management Reporting Programmer to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
This is a contract position with a duration of approximately 8 months.
What you'll be doing:
- Develops and maintains clinical data standards, including operational (electronic Case Report Form (CRF) global library standards), Study Data Tabulation Model (SDTM), controlled terminology, external data mappings (e.g., lab or electrocardiogram), and other applicable standards
- Works across the portfolio and Clinical Study Teams to increase automated reporting (JReview®, SAS) and review in order to streamline effort on data intensive studies
- Develops of 'smart' reports, identifies efficiencies and trends in ongoing review, and develops best practices and data flow solutions
- Enhances available reporting tools or creates new ones to support the review of clinical trial data and trial status information for cross-functional use
- Creates Standard Operating Procedures (SOPs), best practices, educational series, global work streams related to data standards, trial/data status reporting and clinical database creation and testing
- Leads/performs activities related User and Site Account Administration and Maintenance within Clinical Data Management Systems (CDMS) and Electronic Data Capture (EDC) including the definition of best practices and SOPs
- Leads/performs Clinical Trial Management System (CTMS) Technical Administration including the definition of best practices and SOPs
- Ensures vendors support technical data management activities to meet or exceed industry standards related to clinical data collection, processing and quality
- Liaises with Clinical Research Organizations, EDC vendors and other third-party vendors in a project-manager capacity in support of timelines and data-related technical deliverables.
- Liaises with the sponsor as needed to resolve issues that cannot be resolved within the organization.
- Mentor and train Technical Data Managers.
- Performs additional duties as assigned.
You'll need this background to be considered:
- Bachelor degree, or international equivalent from an accredited institution, preferably in a programming, technical, clinical, or health-related field, or equivalent combination of education, training and experience
- Must have Oracle InForm and SQL experience.
- 5 to 7 years of practical experience using commercial clinical data management systems (eg – Oracle RDC / Inform, Medidata Rave, Datalabs, etc) or data visualization tools (e.g. Spotfire, jReview). Alternatively, must have proven experience in all primary job functions
- Proven ability to mentor others by instructing and developing capabilities
- Demonstrates excellent English verbal and written communication skills
- Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)
- Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
- Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities