Site Activation Manager – Oncology

🕒 il y a 13 jours

🇵🇱 Pologne – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

👻 Score fantôme 10%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Worldwide Clinical Trials

Worldwide Clinical Trials

1001 - 5000 employés

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

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

• Accountable for site activation project management and delivery activities within the assigned therapeutic area • Coordinate, collaborate on, and oversee site identification and central and local EC activities for NA countries, essential document collection, investigator and site contract status, and country/study-specific site activation tasks • Provide site activation-related input into proposal text and budget items as needed • Serve as the primary point of accountability for site activation and start-up activities on assigned studies • Oversee cross-functional site activation activities to achieve milestones on time and within budget • Manage tracking, analysis, and reporting of site activation progress and metrics • Partner with project teams on feasibility, site qualification, selection, and regulatory activities • 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 budgeted; track and manage out-of-scope work through change control • Drive continuous improvement through SOP development, best practices, metrics, and departmental initiatives • Contribute to business development, proposal development, and bid defense support • Liaise with internal stakeholders and external vendors, escalating issues to ensure on-time delivery • Ensure compliance with SOPs, ICH GCP, and applicable regulatory requirements • Report to a senior member of the Site Activation leadership team within the assigned therapeutic area

🎯 Exigences

• Strong leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing • Experience and input into initiatives relating to interacting with sites and/or customers • Strong interpersonal, oral, and written communication skills in a fast-paced, deadline-oriented, and changing environment • Demonstrated ability to collaborate across the business • Team-oriented work style: seeks and gives guidance • Understanding of regulatory processes and guidelines • Understanding of initiation, planning, and execution of clinical projects and overall project planning • Awareness of ICH GCP Guidelines and the FDA/EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications) • Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude • 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

• Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law

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