PSI CRO | Clinical Operations Lead
hace 3 semanas
Company Description
PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
We're on the lookout for a knowledgeable, proactive and dedicated person to lead and develop our Clinical Operations team in Mexico. In this role, you will establish local operational presence and enjoy all aspects of operational & strategic management.
The scope of responsibilities will include:
- Line management of Clinical Operations staff
- Management of multiple aspects of clinical research from business development to project execution
- Coordination of resource allocation to projects and utilization monitoring
- Oversight of the staff workload, performance appraisal and career advancement
- Training, coaching and mentoring the team
- Hiring, onboarding and integrating new Clinical Operations’ employees
- Ensuring compliance with GCP standards and internal/external procedures
- Development and implementation of quality control
- Regional project oversight
- Management of the budgets on the country level
- Maintenance, revision and establishment of processes on the regional level
- Ensuring smooth operations of the company in Mexico, providing full managerial and administrative support to all staff in the country
- Communication point to investigators, regulatory and ethics authorities, clients and vendors for various project-related matters
Qualifications
- College or University degree in Life Sciences
- Demonstrated operations experience in a CRO (preferable), or a pharma company
- Experience with clinical research sites, R+D processes, legal, regulatory and ethics in Mexico
- Bid defense experience is preferable
- Knowledge of local HR line management processes
- Excellent communication in English and Spanish
- Proficiency in standard MS Office applications
- Ability to travel locally and internationally
- Strong time management, organizational, leadership, planning and presentation skills, result-oriented approach
Additional Information
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
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