Clinical Monitoring Manager

🕒 vor 3 Monaten

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Apogee Therapeutics

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51 - 200 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

💰 €149.000.000 Series B im 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics ist ein biopharmazeutisches Unternehmen im klinischen Stadium, das sich auf die Entwicklung neuartiger Biologika zur Behandlung von Entzündungs- und Immunerkrankungen konzentriert. Das Unternehmen zielt auf bedeutende Märkte in den Bereichen entzündliche und immunologische Erkrankungen ab, wie z. B. atopische Dermatitis, Asthma, chronisch obstruktive Lungenerkrankung, eosinophile Ösophagitis und andere verwandte Zustände. Apogee Therapeutics strebt an, den aktuellen Behandlungsstandard zu verändern, indem es Antikörpertherapeutika vorantreibt, die auf etablierte biologische Mechanismen abzielen und das Potenzial haben, dermatologische, respiratorische und gastroenterologische Probleme zu adressieren. Das Unternehmen ist dazu verpflichtet, ein psychologisch sicheres Arbeitsumfeld zu schaffen, während es innovative Behandlungsoptionen für Menschen mit diesen Erkrankungen priorisiert.

Beschreibung

• 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

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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