Senior Manager, Clinical Programming

Senior Manager, Clinical Programming The Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of Study Data Tabulation Model (SDTM) standards, performing sponsor oversight of relevant programming activities on the Biometrics vendor, and ensuring the quality and consistency of data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems. Responsibilities Develop and implement company SDTM standards that support the scientific need of a study/program while ensuring quality, consistency, and compliance to CDISC and other industry standards that support the exchange of data, reporting, and analysis. Ensure 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.

Serve as a subject matter expert on all aspects of standards development that includes industry standards (CDISC), regulations, and processes. Ensure study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, and review study submission data packages to ensure quality and integrity. Directly support knowledge development of others as a subject‑matter expert on data standards, reporting, and analysis standards, change control management and related tools/applications.

Create quality control processes, metrics and other measures to ensure compliance with standards. Ensure work is carried out in accordance with applicable SOPs and working practices, as well as global agency regulations/guidance. Create documentation and training for standard processes, change control management and tools.

Define standards specifications working closely with implementation support teams (database set‑up, completion guidelines, CRF designers, procedures, algorithm specifications and reporting requirements). Facilitate 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. Work with Digital Solutions and IT to support the implementation of future strategies and technology‑enabled processes and tools for clinical trial standards, change control management and the exchange of standards information to internal downstream consumers and external consumers.

Serve 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 preferred. At least 6‑8 years of relevant experience in a pharmaceutical, biotech, CRO or regulatory agency.

Proficient in SAS programming with 6‑8 years of experience. Practical knowledge and experience using R to support clinical trials (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 cross‑functional teams delivering on project and portfolio timelines and metrics. Strong verbal and written communication skills; independent and effective working in a multi‑study, multi‑disciplinary matrix environment. Experience in clinical data management and/or trial management with technical expertise in standards management and implementation (preferred).

Salary For US based candidates: $131,040.00 – $196,560.00. Benefits 401(k) Plan: 100% match on 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. #J-18808-Ljbffr