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Global Study Manager
il y a 2 semaines
Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service, functional service provider and consulting - allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
**What we offer**:
The Global Study Manager (GSM) represents & supports Global Clinical Department at study level, collaborating actively with all functions in Clinical and for optimized deliverables.
The GSM is responsible for providing assumptions for number of sites and enrollment rates for budget and planning purposes for all studies within a program.
The GSM is accountable for accurate reporting, study delivery at and to Global Clinical Department upper management.
The GSM coordinates Clinical teams with the Global Clinical Development Strategy Expert (GCDSE) and is accountable for delivering studies with timelines, budget and quality expected. S/he is accountable to develop and maintain optimized study planning with other functions, considering all efficiencies to be gained.
The GSM integrates and follows up study risks, ensuring alignment of all Clinical team members and functions.
**Minimum Requirements**:
- 2+ years’ experience in vaccinology or clinical research
- Formal training in GCP methods
- Proven track record in delivering high quality GCP-compliant Clinical Trials
- Clinical Trial experience required
- Knowledge of Code of Federal Regulations (US) and other regulatory agency documents
- Demonstrated interpersonal skills - ability to work with individuals at different levels
- Independence, self-motivation
- Demonstrated advanced team and negotiation skills
- Resourcefulness; ability to find solutions to operational problems
- Strongly results oriented
- Project management, budget management experience required
- Fluent English communication skills, verbal and written
- Leadership in a multicultural environment
- Positive mindset and behavior - Strong team spirit
- Leadership in a multicultural environment
- Excellent interpersonal and presentation skills
**Summary**:
- Type of job:
Full-time
- Location:
Lyon
- Capability:
Clinical Research
**Contact**:
- **Clara Rousselet-Blanc**
Talent Manager
