Clinical Team Manager, Spanish Speaking

🕒 il y a 14 jours

🌲 North Carolina – Distant

🌲 North Carolina – Remote

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

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ERGOMED

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 1997

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

ERGOMED est un groupe international qui fournit des services spécialisés aux industries biotechnologique et pharmaceutique. Il opère à travers plusieurs lignes de services, notamment Ergomed Clinical Research, PrimeVigilance et ADAMAS Consulting, et se consacre à offrir des capacités complètes de CRO (Contract Research Organization). Axé sur l’oncologie, les maladies rares et les essais complexes, il propose également des services de pharmacovigilance et d’information médicale de bout en bout, ainsi que des audits GxP complets. Ergomed s’engage à accompagner le développement de médicaments, avec une présence mondiale dans une centaine de pays environ.

Description

• The Clinical Team Manager will be responsible for operational project management • The CTM proactively identifies, resolves/mitigates, and escalates risks and/or issues to the PM/PD and Head of Clinical Operations as necessary • Verifying and ensuring that project team members (CRAs, Site Managers, CTAs) are trained (e.g., GCP, SOP, indication, protocol, study specific procedures / requirements, etc.) to perform their assignments • Developing, reviewing and revision of project documents (e.g., monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.) • Initiating corrective / preventative measures – e.g., update of study guidance documents, performing re-training, performing co-monitoring, etc.

🎯 Exigences

• Extensive clinical research lead experience in multiple studies • Experience in managing Clinical part of studies in more than one region or equivalent study complexities • Experience of phase 2/3 trials, ideally complex studies such as oncology or rare disease • Able to work in a fast-paced small CRO environment and manage multiple projects • A minimum of a science-based bachelor’s degree • Able to work effectively with minimal supervision

🏖️ Avantages

• Training and career development opportunities internally • Strong emphasis on personal and professional growth • Friendly, supportive working environment • Opportunity to work with colleagues based all over the world, with English as the company language