Senior Manager, Clinical Programming

Role Overview

• Develops and implements company Study Data Tabulation Model (SDTM) standards that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange of data, reporting, and analysis.
• Ensures alignment of SDTM standards with data collection standards and relevant company tools/system requirements by reviewing study eCRFs, supporting creation of external data collection standards, and providing SDTM mapping guidance
• Serves as a subject matter expert on all aspects of standards development that includes industry standards (CDISC), regulations, and processes
• Ensures study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity
• Directly supports knowledge development of others as a subject matter expert on data standards, reporting and analysis standards, change control management and related tools/applications
• Creates quality control processes, metrics and other measures to ensure compliance with standards
• Ensures work carried out in accordance with applicable SOP’s and working practices, as well as global agency regulations/guidance’s
• Creates any needed documentation and training for standard processes, change control management and tools
• Responsible for defining standards specifications working closely with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications and reporting requirements)
• Facilitates a culture of continuous process improvement and a high level of customer service by maintaining and improving the standards processes associated with standards creation, maintenance, decision-making and implementation
• Working with Digital Solutions and IT, support the implementation of future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal downstream consumers and externally consumers
• Serves as a liaison between Clinical Programming and External Data Management to ensure data standardization alignment and proactively resolve external data issues that impact SDTM deliverables.

Requirements

• Bachelor’s degree in Statistics, Computer Science, Life Sciences. Master’s degree in Statistics, Computer Science, Life Sciences preferred
• At least 6-8 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency
• Proficient in SAS programming, 6-8 years experience
• Practical knowledge and experience using R to support clinical trial preferred
• Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements
• Demonstrated experience managing multiple tasks, complex projects and working with cross functional teams delivering to project and portfolio timelines and metrics
• Strong verbal and written communication skills; independent and effective working in a multi-study, multi-disciplinary atmosphere in a matrix environment
• Experience in clinical data management and/or trial management experience with technical expertise in standards management and implementation is preferred.

Tech Stack

• Google Cloud Platform

Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses