**Descripción**:
Accountabilities:
In collaboration with the integral study team and key vendors, you'll support clinical study execution, ensuring adherence to timelines and quality standards.
- Lead the preparation of study documents and vendor-related documents, such as the Vendor Oversight Plan.
- Facilitate interactions with cross-functional team members, including Data Management, Procurement, Regulatory, Patient Safety, and Quality Assurance.
- Collaborate closely with partners to execute delegated aspects of the clinical study, aligning with objectives set by the GPD, GSAD, or GSM.
- Contribute to planning and execution of internal and external meetings.
- Identify risks and issues, developing mitigation and action plans.
- Support GSM in project and budget management.
- Participate in or lead departmental initiatives and SME functions.
- Mentor team members, promoting professional development and collaboration.
- Provide support for other study and functional activities as assigned.
**Requisitos**:
Essential Skills/Experience:
- Certificate of Disability equal or superior to 33%.
- Bachelor’s degree or equivalent in clinical practice/health care, life sciences, or drug development, or commensurate work experience.
- Proficiency with technological systems (Microsoft Office such as: Excel, PowerPoint, and SharePoint Online, eTMF and Veeva Systems).
- Excellent organizational communication and time management skills.
- Highly proactive and willing to take initiative.
- Strong relationship building skills.
- Ability to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
Desirable Skills/Experience:
- Over 3 years supporting global study teams in a clinical research environment.
- Ability to drive discussions around the scope of work and oversee vendor-related activities.
- Excellent knowledge of Essential Documents, CFR, and/or ICH-GCP.
- Demonstrated ability to collaborate as well as work independently.
- Project management skills and basic PM methodology.