Country Start-up Specialist – Maintenance

🕒 il y a 17 jours

🌽 Illinois – Distant

🌽 Illinois – Remote

💵 $56 400 - $95 900 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

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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Syneos Health

Site WebLinkedInTous les Emplois

10 000+ employés

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Syneos Health est une organisation de solutions biopharmaceutiques entièrement intégrée et leader, conçue pour accélérer le succès des clients. Ils transforment des intuitions cliniques, des affaires médicales et commerciales uniques en résultats pour répondre aux réalités du marché moderne. En utilisant des technologies avancées et des perspectives, Syneos Health collabore avec les clients pour accélérer la livraison de thérapies importantes aux patients dans le monde entier, offrant des services qui couvrent tout le spectre du clinique au commercial.

Description

• Responsible for quality deliverables at the country level and compliance with project requirements and applicable country rules • Track submission and approval timelines and milestone progress in the SSU tracking system • Investigate delays, provide rationale, support contingency plans, and escalate issues • Monitor basic project financial aspects and contracted hours/tasks • Review and comply with SOPs and Work Instructions and maintain training records and timesheet compliance • Support quality improvement across country-level Site Start-Up components • Submit relevant documents to the Trial Master File • Prepare and submit Central EC, Local EC, RA, regulatory authority, and hospital approval applications • Prepare ongoing submissions, amendments, periodic notifications, safety notifications, and renewals • Liaise between investigational sites and functional leads and oversee end-to-end site activation • Maintain country regulatory intelligence and support data protection guidance • Provide input to local SOPs, Work Instructions, and internal training materials • Support EC or Competent Authority issue resolution • Support site selection and feasibility activities • Support country template contracts and budgets, negotiate site-specific contracts and budgets, perform quality control, arrange CTA execution, and archive documents • Coordinate country start-up activities from study award through site activation • Support sites throughout the study lifecycle to ensure regulatory compliance and operational readiness

🎯 Exigences

• Experience in Clinical Research, Study Start-Up, Regulatory Affairs, Clinical Operations, or related functions • Demonstrated experience managing country start-up activities, including regulatory and ethics committee submissions, essential document collection, and study activation processes • Experience supporting study maintenance activities, including protocol amendments, continuing reviews, safety submissions, renewals, and ongoing regulatory compliance • Strong understanding of ICH-GCP guidelines and local regulatory requirements • Experience working with multiple stakeholders, including sponsors, CROs, investigator sites, and regulatory authorities • Strong project management and organizational skills • Strong written and verbal communication and interpersonal skills • Equivalent experience, skills, and/or education will also be considered

🏖️ Avantages

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time