Senior Principal Clinical Research Pharmacist H
- Buenos Aires
- Permanente
- Tiempo completo
- This role will provide clinical research pharmacy expertise in the development and management of investigational products at a program and protocol level (i.e. investigational product handling manuals/pharmacy manuals for utilization by clinical sites)The Clinical Research Pharmacists will provide expertise across Global Clinical Supply (GCS) on clinical site/pharmacy operations; aseptic preparation guidelines for injectables; clinical disease state and patient journey reviews
- Provide a supportive role to Clinical Supply Strategy and Management (CSSM), Medicinal Sciences, Worldwide Research, Development, and Medical (WRDM) and Global Product Development (GPD) on the creation of clinical study protocols and Dosage and Administration Instructions (DAI), specifically providing clinical pharmacy guidance with respect to the handling, preparation, and administration of investigational products at clinical sites to patients and caregivers
- Educate clinical site personnel through in-services, investigator meetings and clinical site initiations or follow-up visits on the proper handling and use of investigational products, when necessary provide consultation to clinical project teams on medication/device related issues, such as concomitant medications, exclusionary medications, and patient compliance/adherence issues
- Assess the risks associated with IP Handling as described in the protocol and develop a CRP Risk Assessment and Mitigation Strategy (CRP RAMS) for the protocol
- Provide patient focus support to the Clinical Supply Team (CST) in the design of clinical labeling and packaging for use in clinical studies
- Provide support to CSSM and GPD on the development of clinical study protocols and DAI, specifically providing clinical pharmacy guidance with thehandling, preparation, and administration of investigational products at clinical sites
- Provide clinical pharmacy expertise in the development and management of investigational product handling manuals/pharmacy manuals for utilization by clinical sites
- Educate clinical site personnel through in-services, investigator meetings and clinical site initiations or follow-up visits on the proper handling and use of investigational products, when necessary
- Provide consultation to clinical project teams on medication/device related issues, such as concomitant medications, exclusionary medications, and patient compliance/adherence issues
- Lead multi-disciplinary initiative teams in the development and implementation of innovative products and processes to optimize investigational product use**Qualifications**:
Must-Have:
- A degree in Pharmacy (PharmD preferred) with 8+ years of Clinical Pharmacy or equivalent pharmaceutical/biotech industry experience- Hospital pharmacy experience required- Clinical Research experience preferred (i.e., CRA/Monitoring)- Work experience must include some of the following: drug development, clinical study design, scientific research, pharmaceutical manufacturing / packaging / labeling, cGMP requirements, leading project teams- Ability to speak major languages (English and Spanish) in the region to communicate with local authorities & partners, and read local documents related to clinical supplies- Demonstrated experience of managing and measuring work, negotiation, conflict management, influencing, process improvement and project management- Great verbal and written communication skills with strong internal and external relationship management skills- Advanced Microsoft Office Suite skills and strong competency with toolsNice-to-Have:
- Completion of a post-PharmD Industry Fellowship or pharmacy practice residency is desirable- Sterile product compounding experience a plus- Project Management certification- Demonstrate skills with technical, planning, analytical and financial disciplines- Customer oriented, ability to work
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