Clinical Monitoring Manager

Role Overview

• 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

Requirements

• 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.

Tech Stack

• Google Cloud Platform

Benefits

• 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