5 дней назад
Senior Clinical Operations Lead (Biopharmaceutical Clinical Trials)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Clinical Operations Lead (Biopharmaceutical Clinical Trials): Supporting the execution of multinational clinical trials through site coordination, clinical documentation, vendor management, and study timeline oversight with an accent on ICH Good Clinical Practices, investigational site operations, and cross-functional safety coordination. Focus on coordinating external vendors, resolving clinical data discrepancies, managing trial deliverables, and supporting recruitment and patient retention strategies.
Location: Fully remote; position associated with Wilmington, Delaware, United States
Company
is a global biopharmaceutical company developing proprietary therapeutics in Hematology, Oncology, Inflammation, and Autoimmunity, with operations across North America, Europe, and Asia.
What you will do
- Support Clinical Trial Managers and operational teams in executing clinical trials.
- Coordinate with CROs, investigational sites, laboratories, monitoring organizations, and other external vendors.
- Review, develop, and maintain clinical trial documents, study manuals, laboratory plans, biomarker plans, and informed consent templates.
- Coordinate site feasibility, monitoring activities, recruitment tools, patient retention plans, study timelines, and key deliverables.
- Support investigational product and co-medication strategy, data review, discrepancy resolution, and pharmacovigilance coordination.
- Organize investigator, coordinator, data monitoring, safety, and other cross-functional study meetings.
Requirements
- BS/BA degree or another relevant degree with a strong emphasis on science.
- At least three years of experience in the biopharmaceutical industry or relevant clinical research.
- Working knowledge of ICH Good Clinical Practices and applicable regulatory and health authority requirements.
- Ability to manage multiple priorities across several protocols and therapeutic areas simultaneously.
- Ability to communicate effectively with internal teams, CROs, vendors, and investigational sites.
Nice to have
- Experience assisting with the conduct and management of multinational clinical trials.
Culture & Benefits
- Fully remote work arrangement.
- Opportunity to contribute to clinical development programs addressing unmet medical needs.
- Work within multidisciplinary trial teams spanning international operations.
- Equal opportunity workplace committed to creating a diverse environment.
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