Clinical Project Manager
Il y a 3 mois
About Balt
Our purpose is to improve the lives of 150,000 patients in 2026.
Our story
Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting.
We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.
We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.
Why Join Balt? Join a passionate team, dedicated to making a difference.
Working at Balt means giving meaning to your work Pride is a strong part of our identity.
We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
No matter the country, we take care of you.
Would you like to be part of our story?
Don't hesitate, come and join us
About the Opportunity
Reporting to the Manager Clinical Operations – International (based in France), you will be responsible and accountable for the management and coordination of one or more clinical trial(s) and for trial audit readiness (project team training records, central files, system validation, etc.)
Job responsibilities:
- Manages the project(s) within the approved budgets and timelines
- Directly in charge of the selection, contracting, coordination and management of the CROs and providers contracted for a given project
- Responsible for writing and/or supervising the CROs for the development of clinical project deliverables such as study manuals, study tools and operational plans
- Participates in writing of clinical project deliverables such as protocols, study reports and CRFs
- Prepares investigational site lists and participates in reviewing and approving investigational sites
- Prepares and presents the status of the clinical project(s) to the Clinical Management
- Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
- Responsible for corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits
- Demonstrates thorough knowledge in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BALT SOPs and policies
Qualification requirements:
- Master’s degree in Life science or related field (Bac +5)
- Minimum 5 years’ experience in the clinical research field
- 2-3 years’ experience as clinical project manager in medical devices/pharmaceutical industry, in a CRO or in an institutional promoter
- Ability to develop good interpersonal relationships with medical professionals
- Excellent verbal and written communication in English and presentation skills
- A second language is an asset (Spanish, German or Italian)
- Must be familiar with the laws, regulations, standards and guidance governing the conduct of clinical studies
- Ability to independently manage and provide trials status to the project team
- Excellent skills in project management and planification
- Comfortable with project management tools
- Team player who is able to prioritize workload in a fast-paced environment
- Independent thinker with ability to anticipate issues and risks and to mitigate accordingly
- Creative thinker who can troubleshoot issues and think outside of the box to achieve Project goals
- Flexibility and availability to travel in France and Europe (10%)
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