Apogee Therapeutics

Clinical Monitoring Manager

ManagerManagerFull TimeRemoteLeadTeam 51-200H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

93 days ago

Salary

$150K - $170K / year

Seniority

Lead

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

• 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

Job 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