3 дня назад
Manager, Precision Medicine Operations
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, Precision Medicine Operations (Clinical Laboratory Study Management): Leading clinical laboratory study management for precision medicine trials, including sample collection, testing, logistics, and data transfer with an accent on biospecimen operations, clinical trial compliance, and cross-functional delivery. Focus on building laboratory databases, overseeing study life cycles, resolving sample-related issues, and coordinating sample and testing data specifications with laboratories, CROs, clinical teams, and data management.
Location: Dublin, Ireland; 3 days per week on site
Company
is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.
What you will do
- Lead and develop a team of Clinical Laboratory Study Managers across therapeutic areas, including immuno-oncology.
- Build laboratory databases covering clinical trial sample collection, kits, testing, and logistics.
- Monitor the acquisition of human tissue, bone marrow aspirate, blood, plasma, serum, and other clinical trial samples while ensuring compliance with informed consent permissions.
- Oversee study start-up, closeout, and lifecycle activities at central and specialty laboratories.
- Coordinate with clinical study teams, CROs, laboratory project managers, data management, and logistics stakeholders to resolve sample-related issues.
- Develop and review data transfer specifications to support the capture, blinding, and transfer of sample and testing data.
Requirements
- Bachelor’s degree and at least 8 years of pharmaceutical experience in matrixed, cross-functional environments.
- At least 5 years of clinical trial experience focused on clinical sample collection.
- Extensive experience in clinical laboratory operations, biospecimen logistics, and/or clinical studies.
- Strong understanding of the technical, clinical, and strategic aspects of laboratory operations delivery.
- Availability to work onsite in Dublin 3 days per week.
Culture & Benefits
- Inclusive workplace and equal opportunity employment.
- Competitive total rewards package, which may include bonuses, equity awards, pension or retirement benefits, insurance, paid time off, and family support benefits.
- Reasonable accommodation is available during recruitment where required by applicable law.
- Background checks may verify identity, right to work, and educational qualifications.
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