Clinical Operation Manager - Roma, Italia - EastHORN Clinical Services

Descrizione

Job summary:

As an experienced
Clinical Operations Manager you will be expected to develop and grow the team in France and support clients relationships for the assigned region.

Reporting to the Executive Director Clinical Operations, you will be a key member of the
Clinical Operations team.
We are searching for an experienced, ambitious and energetic person.

The desired person shall be open to cross cultures communication and cooperation and shall be significantly independent in their performance.

Main Tasks of the Position:

• Responsible for setting up a physical office in France ( city is TBC) and willingness to work from this office 2 days per week and if needed
• Manages the daytoday activities necessary for the successful completion of a project within EastHORN and client timelines and budget
• Responsible for establishing excellent working relationships with client project teams to ensure client satisfaction and operational excellence
• Supports business development activities in assigned region/ might participate in Business Development meeting calls or meetings with a Client and coordinates feasibility process
• Defines and manages project resource needs to ensure ontime and onbudget deliverables for assigned projects: completes allocation and demand table, reviews and approves timesheets
• Serves as the Project Lead for key business development opportunities, including the preparation and delivery of client presentations
• Provides Line Management to assigned staff
• Provides ongoing leadership and performance feedback to project team members
• Supports preparation of the study budget and site contract negotiations
• Identifies, contacts and manages external vendors if required for a successful study conduct
• Acts as an expert in regulatory affairs and operations in related CEE countries; supports regulatory submission and site contract negotiation processes
• Responsible for detailed performance review, identification of training needs and performance issues, and resolution of all issues for assigned Clinical Operations staff
• Conducts Quality Control and Comonitoring visits with Clinical Research Associates to identify and ensure good performance and quality
• Responsible for clinical resource management and work allocation
• Assists in the clinical staff recruitment process
• May have administrative Head of Office role for EastHORN's assigned countries that includes overseeing legal aspects of EastHORN local office including, but not limited to: legal address, rent of the office, office admin supervision, admin supplies supervision, etc.

; be responsible for finance aspects:
country budget, salaries and bonuses, expenses approval etc.


Required Qualifications, Experience, Competencies

• 10+ years' experience in clinical research
• 5+ years' experience as manager in a CRO

- experiences with regulatory submissions and monitoring in other francophone countries (Switzerland, Belgium) is an asset

• Excellent knowledge of ICH-GCP guidelines
• Be aware of drug development process, in particular monitoring and site management skills
• Excellent skills to lead a clinical project team and to encourage team members to seek solutions
• Demonstrated skills to coach and mentor other clinical staff
• Excellent communication, presentation, interpersonal, and change management skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Excellent planning, time management and organizational skills to handle multiple priorities
• Ability to work independently and within a team environment
• Strong analytical capabilities and a very detailoriented mindset
• Knowledge of basic financial concepts as related to forecasting and budgeting. Understands project budgets
• Excellent written and oral communication skills in English and Italian

Benefits:

• Working with experienced and very professional and supportive team
• Possibility to grow and develop within the Company
• Competitive remuneration
• Flexible working time
• Eligibility to the Company Bonus scheme
• Benefits according to the country package