Clinical Project Manager
il y a 5 jours
Balt is a pioneering medical device company that has been leading the way in the development of innovative solutions for over 45 years. Our mission is to improve the lives of patients worldwide by providing cutting-edge medical devices that empower physicians to save lives.
We have a strong presence in 11 countries, with 13 offices and a team of dedicated professionals who share our passion for making a difference. Our products are used by physicians across the globe, and we continue to expand our portfolio of medical devices to address the needs of patients with neurological and vascular conditions.
Our StoryBalt's story began in 1977, when we introduced one of the first neurovascular intervention devices. Since then, we have continued to innovate and push the boundaries of what is possible in medical device development. Our commitment to excellence and our passion for making a difference have driven us to become a leader in the industry.
We are proud of our achievements and the impact we have made on the lives of patients. Our team is dedicated to delivering high-quality products and services that meet the needs of our customers and stakeholders. We are committed to continuous improvement and to staying at the forefront of medical device development.
Why Work at Balt?At Balt, we offer a unique opportunity to be part of a dynamic and innovative team that is making a real difference in the lives of patients. We are a close-knit team that values collaboration, respect, and open communication. We are committed to providing a positive and inclusive work environment that supports the growth and development of our employees.
We offer a range of benefits and opportunities for professional development, including training and education programs, mentorship, and career advancement opportunities. We are committed to recognizing and rewarding our employees for their contributions and achievements.
About the OpportunityWe are seeking a highly skilled and experienced Clinical Project Manager to join our team. The successful candidate will be responsible for managing and coordinating clinical trials, ensuring that they are conducted in accordance with regulatory requirements and company policies. The Clinical Project Manager will work closely with cross-functional teams, including clinical operations, regulatory affairs, and quality assurance, to ensure that clinical trials are conducted efficiently and effectively.
The Clinical Project Manager will be responsible for:
- Managing clinical trials within approved budgets and timelines
- Selecting, contracting, and managing CROs and providers
- Developing clinical project deliverables, including study manuals, study tools, and operational plans
- Participating in the development of clinical project deliverables, including protocols, study reports, and CRFs
- Preparing investigational site lists and reviewing and approving investigational sites
- Preparing and presenting clinical project status to the Clinical Management
- Providing oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses are developed and executed
- Responsible for corrective action plans at individual sites and across trial
- Demonstrating thorough knowledge in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BALT SOPs and policies
The successful candidate will have:
- A 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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