Clinical Monitoring Manager

🕒 Março 2

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Apogee Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

💰 $149.000.000 Series B em 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics é uma empresa de biotecnologia em fase clínica focada no desenvolvimento de novos biológicos para o tratamento de distúrbios inflamatórios e imunológicos. A empresa mira mercados principais em doenças inflamatórias e imunológicas como dermatite atópica, asma, doença pulmonar obstrutiva crônica, esofagite eosinofílica e outras condições relacionadas. A Apogee Therapeutics busca reformular o padrão atual de cuidados ao avançar terapias com anticorpos que visam mecanismos biológicos bem estabelecidos, com potencial para atender questões dermatológicas, respiratórias e gastroenterológicas. A empresa está comprometida em criar um ambiente de trabalho psicologicamente seguro enquanto prioriza opções de tratamento inovadoras para aqueles que vivem com essas condições.

Descrição

• Oversee in-house Oversight CRAs that will oversee CRO CRA’s management of clinical study site activities for Apogee sponsored clinical trials • Support the study team in various trial related activities • Serve as Apogee’s primary liaison with the in-house CRAs and CRO clinical monitoring team and liaise with clinical study sites • Contribute to building a culture of team, site and patient centricity • Accountable for oversight of clinical monitoring activities from site identification through close out of the study site • Collaborate closely with the Apogee Executive Director, Clinical Operations and the Clinical Study Lead • Assist in the planning/management/execution of Apogee sponsored clinical trials • Contribute to the overall success of the clinical study according to company and department objectives

🎯 Requisitos

• Bachelor's degree in a scientific or healthcare-related field • Minimum of 8 years of experience as a CRA or related role within the pharmaceutical, biotechnology, or medical device industry • Minimum 2 years of experience leading a team of CRAs • Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials a plus • Certification as a Clinical Research Associate (CCRA) or equivalent preferred • Recent experience working on trials utilizing risk-based monitoring models • Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP), and FDA regulations • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet • Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems • Strong understanding of clinical trial processes and study conduct • Excellent organizational and time management skills • Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight • Experience working in a fast-paced and dynamic environment • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless • Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.

🏖️ Benefícios

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve