Site Activation Manager

🕒 il y a 1 mois

🌲 North Carolina – Distant

🌲 North Carolina – Remote

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

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Worldwide Clinical Trials

Site WebLinkedInTous les Emplois

1001 - 5000 employés

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Worldwide Clinical Trials est une organisation mondiale de recherche contractuelle (CRO) qui offre des services complets d'essais cliniques. Ils se spécialisent dans le soutien aux études dans divers domaines thérapeutiques tels que l'oncologie, la cardiologie et les maladies rares. Avec plus de 30 ans d'expérience, Worldwide Clinical Trials met l'accent sur un soutien personnalisé et des solutions sur mesure tout au long du cycle de développement des médicaments. Leurs services incluent la surveillance clinique, la gestion des données, le recrutement de patients et le conseil réglementaire, garantissant précision et attention sur-mesure pour chaque essai clinique.

Description

• Serve as the primary point of accountability for site activation and start‑up activities on assigned studies • Oversee cross‑functional site activation activities to ensure milestones are achieved on time and within budget • Manage the accurate tracking, analysis, and reporting of site activation progress and metrics • Partner with project teams to support feasibility, site qualification, selection , and regulatory activities as needed • Communicate site activation status, risks, and mitigation plans to Sponsors , project leadership, and internal teams • Develop and maintain site activation project plans and support risk assessment and issue resolution • Ensure site activation activities are appropriately budgeted, with out‑of‑scope work tracked and managed through change control • Drive continuous improvement through SOP development, best practices, metrics, and departmental initiatives • Contribute to business development activities, including proposal development and bid defense support • Liaise with internal stakeholders and external vendors, escalating issues as needed to ensure on‑time delivery • Ensure compliance with SOPs, ICH GCP, and applicable regulatory requirements

🎯 Exigences

• A minimum four-year degree or nursing degree is required • Minimum of 4 years CRO experience in Study Start-Up with country lead or manager experience required • Proficient in cross-cultural communication • Proficient in both spoken and written English

🏖️ Avantages

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities