1 час назад
Senior Data Management Associate (Clinical Data Management)
115 260 - 149 160$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Data Management Associate (Clinical Data Management): Overseeing clinical data management for complex oncology and cell therapy studies from start-up to close-out with an accent on data quality, eCRF design, external data coordination, and regulatory compliance. Focus on leading cross-functional study deliverables, resolving clinical data queries, coordinating database snapshots, and managing vendor data processes.
Location: United States – Remote
Salary: $115,260–$149,160 per year, with potential discretionary bonus, stock-based long-term incentives, paid time off, and benefits.
Company
is a biopharmaceutical company developing cancer immunotherapies, including CAR T-cell and TCR-engineered cell therapies.
What you will do
- Oversee clinical data management studies from start-up through close-out across complex clinical development programs.
- Coordinate with Clinical Operations, Biostatistics, Statistical Programming, Safety, Regulatory, investigators, and external vendors.
- Lead eCRF preparation and design, protocol review, data management planning, and study timelines.
- Ensure clinical data completeness, accuracy, consistency, quality, and regulatory compliance.
- Manage query resolution, external data transfers, data cleaning, reporting, database snapshots, and analysis readiness.
- Lead study projects independently, facilitate meetings, delegate work, and escalate project-level issues.
Requirements
- High school diploma and 9+ years of data management experience; or a BS/BA and 5+ years; or an MS/MA and 3+ years; or a PhD and 2+ years.
- Experience with web-based electronic data capture systems such as Medidata Rave.
- Strong verbal, written, communication, interpersonal, presentation, and problem-solving skills.
- Ability to manage multiple complex studies, changing priorities, timelines, deliverables, and cross-functional collaboration.
- Knowledge of clinical data management processes, data quality practices, and regulatory compliance.
- Must be based in the United States for this remote position.
Nice to have
- Oncology clinical data management experience, including hematological cancers or cell therapy.
- Scientific background and laboratory data-handling experience.
- Knowledge of FDA, EMA, and ICH clinical trial, statistics, and data management guidelines.
- Experience managing clinical data deliverables for regulatory submissions.
- Familiarity with MedDRA and WHODD thesauri or dictionaries.
Culture & Benefits
- Mission-driven work focused on developing cancer therapies and reducing the burden of chronic care.
- Inclusive work environment that supports diverse perspectives and individual differences.
- Company-sponsored medical, dental, vision, and life insurance plans.
- Paid time off and potential annual bonus and stock-based long-term incentives.
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