Site Activation Manager

🕒 il y a 1 mois

🌲 North Carolina – Distant

🌲 North Carolina – Remote

💵 $86 000 - $170 000 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 6%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Worldwide Clinical Trials

Site WebLinkedInTous les Emplois

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

• Serve as the primary point of communication and accountability for study start-up and maintenance activities on assigned projects • Oversee functional groups involved in site activation to ensure critical path activities are completed on time and within budget • Compile, manage, track, and analyze site activation activities • Support feasibility and site identification activities as needed • Expedite the Site Qualification and Selection process • Communicate Site Activation & Regulatory project status to the Sponsor, GPL/CPM, and project team • Prepare risk assessment and mitigation plans for project deliverables • Ensure relevant study activities are included in the work order budget • Track out-of-scope activities and follow through on change orders • Develop and maintain site activation-related project plans • Contribute to SOPs, best-practice guidelines, training, and coaching • Provide input to departmental process improvement initiatives • Establish and interpret site activation metrics to drive corrective action • Contribute to proposals, budgets, and bid defense meetings • Report or escalate issues to appropriate Site Activation leadership • Comply with SOPs, ICH GCP, and applicable regulations • Liaise with functional contributors and vendors • Perform other duties as assigned

🎯 Exigences

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science OR two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and experience within clinical research (e.g. CRA, Reg Affairs) • Minimum of 4 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience • Proficient in cross-cultural communication • Proficient in both spoken and written English • 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 • Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude • Strong leadership and organizational management skills • Ability to exercise sound judgment, make decisions independently, and proactively identify and solve problems • Ability to motivate, lead and engage a team • Strong interpersonal, oral, and written communication skills • Demonstrated ability to collaborate across the business • Ability to handle multiple tasks in a fast-paced and constantly changing environment • Ability to work in an organized, methodical, and self-motivated manner

🏖️ Avantages

• Competitive benefits package depending on location • Transparent compensation and pay equity