Clinical Monitoring Manager
Apogee Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $150,000 - $170,000 per year
Job Level
SeniorLead
Tech Stack
Google Cloud Platform
About the role
- 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
- Liaise with clinical study sites and contribute to building a culture of team, site and patient centricity
- Help Apogee become “Sponsor of Choice” with both our CRO partners and sites
- 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
- Position requires up to 35% travel
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical research associateclinical trial managementrisk-based monitoringclinical trial processesstudy conductdata managementmonitoring activitiessite identificationclose out proceduresteam leadership
Soft skills
organizational skillstime managementcommunication skillsinterpersonal skillscollaborative skillsindependent workteam-centric approachproblem-solvingadaptabilityattention to detail
Certifications
Clinical Research Associate (CCRA)