Senior Manager, Clinical Programming

🕒 Maio 21

🏖️ New Jersey – Remoto

🏖️ New Jersey – Remote

💵 $131.040 - $196.560 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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Genmab

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1999

🧬 Biotecnologia

💰 $134.000.000 Post-IPO Equity em 2010-06

Biotechnology

Genmab é uma empresa de biotecnologia focada em transformar vidas por meio da ciência pioneira de anticorpos. A empresa é dedicada ao desenvolvimento de terapias inovadoras com anticorpos para diversas doenças, com o objetivo de melhorar os resultados dos pacientes e as opções de tratamento. Os esforços da Genmab em pesquisa e desenvolvimento de anticorpos destacam seu compromisso em avançar na ciência médica.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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