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Sr Clin Data Mgmt Assoc
115 260 - 149 160$
Описание вакансии
Текст:
TL;DR
Sr Clin Data Mgmt Assoc (Clinical Data Management/Oncology): Overseeing clinical data management studies from start-up to close-out, coordinating data collection, quality checking, reporting, and external data deliverables with cross-functional clinical teams, with an accent on complex studies, eCRF design, and regulatory-compliant data processes. Focus on reviewing clinical data, managing queries and database snapshots, coordinating vendors, and resolving project-level issues across clinical development programs.
Location: United States – Remote
Salary: $115,260–$149,160 per year, plus potential annual bonus, stock-based long-term incentives, paid time off, and benefits.
Company
is a biopharmaceutical company developing cancer immunotherapies, including CAR T-cell and T-cell receptor engineered therapies.
What you will do
- Oversee clinical data management studies from start-up through close-out across Kite’s clinical development programs.
- Coordinate clinical data collection, quality checking, reporting, timelines, and database snapshots with Clinical Operations, Biostatistics, Statistical Programming, Safety, Regulatory, and other teams.
- Lead eCRF preparation and design, protocol review, data management planning, and implementation.
- Review clinical data, manage queries, resolve issues with investigators and site staff, and ensure completeness, accuracy, consistency, and timely delivery.
- Coordinate external vendor data collection, cleaning, transfers, documentation, and deliverables.
- Lead studies and projects, facilitate meetings, delegate tasks, and escalate project-level issues involving processes, timelines, resourcing, or performance.
Requirements
- High school diploma with 9+ years of data management experience, or a BS/BA with 5+ years, an MS/MA with 3+ years, or a PhD with 2+ years in data management.
- Experience with web-based electronic data capture systems such as Medidata Rave and other clinical data management systems.
- Ability to manage multiple complex studies, lead projects independently, and communicate technical clinical data management topics to non-specialists.
- Strong verbal, written, interpersonal, problem-solving, presentation, facilitation, and task delegation skills.
- Ability to follow standard clinical data management processes and support regulatory compliance.
Nice to have
- Oncology clinical data management experience, particularly with hematological cancers, cell therapy, and laboratory data.
- Knowledge of FDA, EMA, and ICH clinical trial, statistics, and data management guidelines.
- Experience managing clinical data management deliverables for regulatory submissions.
- Familiarity with MedDRA and WHODD dictionaries.
Culture & Benefits
- Full-time remote work in the United States.
- Medical, dental, vision, and life insurance plans.
- Paid time off and potential discretionary bonus and stock-based long-term incentives.
- Inclusive work environment focused on collaboration, development, and employee empowerment.