Associate Director, Clinical Trial Management

🕒 Março 14

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NewAmsterdam Pharma Corporation

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2019

🧬 Biotecnologia

💊 Farmacêutico

💰 $175.300.000 Post IPO equity em 2024-03

Biotechnology • Pharmaceuticals

A NewAmsterdam Pharma Corporation é uma empresa biofarmacêutica em estágio clínico, focada no desenvolvimento de terapias para doenças cardiovasculares e outras condições relacionadas aos lipídios. A empresa está avançando com o obicetrapib, um inibidor de CETP, e outros programas destinados a reduzir o LDL-C e diminuir o risco cardiovascular para pacientes que têm necessidades não atendidas, apesar dos tratamentos redutores de lipídios existentes. A NewAmsterdam enfatiza o desenvolvimento baseado em ciência, ensaios clínicos e iniciativas focadas no paciente.

Descrição

• Support the planning, initiation, execution, and closeout of clinical trials • Coordinates clinical trial operational activities to ensure completion according to project timelines and budget • Ensure clinical trials are conducted in compliance with NewAmsterdam Pharma SOPs, GCP/ICH and any other regulatory requirements • Manage, and review clinical trial documentation, including protocols, informed consent forms, study plans, and reports • Ensure the collection, management, and reporting of clinical trial data meets the highest standards of quality • Identify and resolve issues related to trial data, patient recruitment and retention, and site performance • Manages clinical trial timelines, enrollment and patient retention objectives • Support of cross-functional teams including representatives from multiple disciplines (e.g. Regulatory Affairs, CMC, etc.) • Review and oversight of clinical trial regulatory packages prepared by the CRO • Oversight of vendor and CRO activities

🎯 Requisitos

• Bachelor’s degree in a scientific discipline, RN, or equivalent • PMP preferred • 5+ years Phase 1-3 global clinical trial operations experience • Demonstrated experience managing external vendors/CROs • Experience in cardiovascular disease strongly preferred • Advanced knowledge of GCP, ICH and FDA regulatory requirements • Proficiency with clinical trial management systems (CTMS) and other related software • Proficient in MS Office (e.g. Outlook, Word, PowerPoint, Excel)

🏖️ Benefícios

• Health insurance • Dental and vision coverage • Term life and disability coverage • Retirement plans