5 дней назад
Program Delivery Manager IP Administration
68 400 - 171 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Program Delivery Manager IP Administration (Clinical Research/Nursing): Developing and implementing safe, efficient investigational product administration processes and training for clinical trials with an accent on IPPI co-authoring, nursing procedures, site support, and cross-functional coordination. Focus on resolving complex administration issues, assessing clinical sites, training internal and site personnel, and maintaining adherence to regulatory and study requirements.
Location: Durham, North Carolina, United States of America
Salary: $68,400–$171,000 annualized
Company
IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Serve as a subject matter expert for nursing administration and investigational product preparation and administration instructions (IPPI) in clinical trials.
- Co-author IPPIs and review forms covering administration routes, IV access devices, priming and flushing, filters, hygiene standards, and medical devices.
- Develop training materials, assess training needs, and train internal staff and site personnel on IP administration procedures.
- Support site assessments, study feasibility, site initiation visits, mock runs, and resolution of IPPI-related site issues.
- Coordinate with study teams, site managers, ancillary supply teams, clinical supply specialists, physicians, scientists, and investigators.
- Track nursing practice trends, contribute to process improvement, maintain study documentation, and complete CTMS and electronic trial master file activities.
Requirements
- Degree in general nursing.
- 3–4 years of recent clinical or hospital experience; relevant equivalent experience may also be considered.
- Experience with antibody treatment, oncology, hematology, solid tumors, and/or immunology, plus clinical trial research experience.
- Knowledge of drug development and ICH/Good Clinical Practice is an asset.
- Strong leadership, mentoring, influencing, communication, problem-solving, decision-making, and organizational skills.
- Proficiency in spoken and written English and the local country language is required.
Culture & Benefits
- Work across a matrix organization with clinical research, medical, quality, compliance, and site teams.
- Support multiple clinical trials in parallel across different disease areas.
- Use virtual meeting software, Microsoft Word, PowerPoint, Excel, and clinical systems.
- Health and welfare benefits may be provided depending on the position and employment terms.
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