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Senior Clinical Research Manager
hace 7 días
This role is primarily accountable for the end-to-end performance and project management for assigned protocols in compliance with country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. The Senior Clinical Research Manager could be responsible for a particular study for several countries in a cluster.
**CORE Competency **Expectations**
**Experience Requirements**:
**Required**:
**1. 5-6 years of experience in clinical research - CRA Experience preferred**
**2. Educational Requirements**:
**Bachelor degree in Science (or comparable)**
**Preferred: Advanced degree, (e.g., Master degree, MD, **PHD**
3. Fluent Spanish and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
4. Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
5. Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
6. Knowledge in Project Management and site management.
7. Strong organizational skills with demonstrated success required.
8. Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Head /CRD
9. Requires strong understanding of local regulatory environment
10. Strong scientific and clinical research knowledge is required
11. Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
12. Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions
13. Strategic thinking
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**:
No
**Travel Requirements**:
No Travel Required
**Flexible Work Arrangements**:
Hybrid
**Shift**:
Not Indicated
**Valid Driving License**:
No
**Hazardous Material(s)**:
no
**Requisition ID**:R284284
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