16 часов назад
Clinical Research Manager II - Pediatric Stem Cell Transplant
94 500 - 113 700$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Manager II - Pediatric Stem Cell Transplant (Clinical Trials): Overseeing pediatric therapeutic and non-therapeutic clinical trials, regulatory compliance, data quality, patient enrollment, study finances, and research staff with an accent on GCP, protocol adherence, and patient safety. Focus on managing complex regulatory requirements, maintaining trial data and documentation, supervising clinical research personnel, and coordinating study operations across institutional and sponsor stakeholders.
Location: Brookline, Massachusetts, United States; hybrid with 2–3 days onsite per week
Salary: $94,500–$113,700 per year
Company
conducts cancer research, provides patient care, and advances treatment through clinical research and education.
What you will do
- Oversee the pediatric clinical trial portfolio across study start-up, active conduct, and close-out phases.
- Coordinate protocol submissions, regulatory reporting, compliance monitoring, and transitions to electronic regulatory binders.
- Manage patient enrollment, protocol treatment, follow-up care, registration, study data entry, and clinical trial management system reporting.
- Develop tracking systems and corrective actions to maintain data quality, protocol adherence, and timely reporting.
- Support protocol budgets, study finances, procurement, inventory, grant reporting, and manuscript preparation.
- Recruit, supervise, train, and evaluate clinical research coordinators and other research staff.
Requirements
- Bachelor’s degree with at least 5 years of related experience, or a master’s degree with 5 years of related experience.
- Very proficient knowledge of clinical trial operations, GCP, local policies, and federal and state research regulations.
- Knowledge of cancer, cancer treatment modalities, clinical trial processes, protocol development, and data compilation and analysis.
- Experience managing complex regulatory scenarios, personnel issues, supervision, and critical feedback.
- Computer skills including Microsoft Office and working knowledge of Livelink, EPIC, and OnCore.
- Ability to work onsite in Brookline 2–3 days per week.
Culture & Benefits
- Work in an innovative, caring, inclusive, diverse, and equitable clinical research environment.
- Collaborate with physicians, research nursing staff, the Clinical Trials Office, regulatory offices, sponsors, and Harvard Medical School-affiliated hospitals.
- Support research that advances cancer treatment and improves patient care.
- Interact with pediatric patients and their families or guardians.
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