Clinical Trial Manager

Lyonbiopôle Auvergne-Rhône-Alpes; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

Une entreprise innovante dans le domaine de la recherche clinique recherche un Clinical Trial Manager passionné pour rejoindre son équipe dynamique. Ce rôle vous permettra de gérer des projets cliniques variés, en mettant à profit votre expertise dans des domaines thérapeutiques tels que l'oncologie et les maladies cardiovasculaires. Vous bénéficierez d'une flexibilité de travail à distance, tout en ayant l'opportunité de diriger des équipes et de superviser des essais cliniques de grande envergure. Si vous êtes prêt à relever des défis stimulants et à contribuer à des projets significatifs, cette opportunité est faite pour vous.

Qualifications

• Minimum de 5 ans d'expérience en gestion d'essais cliniques, de préférence en CRO.
• Expérience dans les phases 1-4 des essais cliniques.

Responsibilities

• Gérer les opérations quotidiennes du projet selon les règles ICH/GCP.
• Servir de contact principal pour les questions opérationnelles du sponsor.

Skills

Gestion de projet

Compétences en leadership

Connaissance des essais cliniques

Communication en français et anglais

Education

Licence en sciences de la santé ou de la vie

Diplôme avancé en sciences de la santé ou de la vie

Job description

Le poste

Clinical Trial Manager

Medpace is the leading CRO for Biotech companies and is continuing to add Clinical Trial Managers of different experience levels to join our Clinical Trial Management Group in Lyon. Clinical Trial Managers with expertise in Oncology/Cardiovascular/Endocrine/Metabolic/ Neuroscience/CNS/Ophthalmology/Infection/Nephrology are welcome to continue to work in their area of expertise or to expand to a new therapeutic area. We provide remote flexibility only with relevant experience. We offer a very competitive salary/bonus program, plus equity grants which have become very lucrative for our associates.

Responsibilities

• Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
• Serve as primary Sponsor contact for operational project-specific issues and study deliverables
• Maintain in depth knowledge of protocol, therapeutic area, and indication
• Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided
• Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable
• Develop operational project plans
• Manage risk assessment and execution
• Responsible for management of study vendor
• Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables

Qualifications

• Bachelor's degree in a health or life science-related field; Advanced degree in a health or life science-related field preferred;
• Experience in Phases 1-4; Phases 2-3 preferred;
• Minimum of 5 years of Clinical Trial Management experience, CRO experience preferred;
• 5+ years of Project Manager/Clinical Trial Manager experience at a CRO required for a remote-based role;
• Management of overall project timeline;
• Bid defense experience preferred;
• Strong leadership skills.
• Language: Fluent French / English

Please apply via the link provided to our careers site.

L'entreprise

Medpace

Medpace is a global Clinical Research Organisation (CRO) partnering with leading pharmaceutical, biotech, and device companies to bring promising new drugs and devices to market. Medpace combines efficient clinical trial management with comprehensive regulatory consulting to provide clients with exceptional support during the drug development process. We manage the full drug and device development process for our clients which includes many components: clinical development plan preparation, project management, regulatory document preparation, safety surveillance, clinical monitoring, data management, statistical analysis, medical writing, quality assurance auditing, and regulatory submissions.

Employing almost 6,000 people across 40+ countries, our people are our biggest asset and embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return, they are rewarded with interesting projects, career advancement, and recognition. Whether you are a recent graduate or seasoned in your field, your contributions can make an impact on our business.