Senior Manager, Clinical Programming

Genmab

Senior Manager overseeing clinical programming and development of SDTM standards at Genmab. Ensuring data standards compliance and quality for clinical trials and regulatory submissions.

Posted 5/21/2026full-timeRemote • New Jersey • 🇺🇸 United StatesSenior💰 $131,040 - $196,560 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

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

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Applicant Tracking System Keywords

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Hard Skills & Tools

SAS programmingR programmingSDTM standardsdata mappingquality control processesmetadata managementclinical data managementchange control managementreporting requirementsalgorithm specifications

Soft Skills

strong verbal communicationstrong written communicationindependent workingeffective teamworkproject managementcross-functional collaborationcustomer serviceprocess improvementproblem-solvingtraining development