Clinical Monitoring Manager Job at Apogee Therapeutics

Job Description

We are seeking a Clinical Monitoring Manager to oversee in-house Oversight CRAs that will oversee CRO CRA’s management of clinical study site activities for Apogee sponsored clinical trials. This role will also support the study team in various trial related activities. In this role, you will serve as Apogee’s primary liaison with the in-house CRAs and CRO clinical monitoring team and liaise with clinical study sites and contribute to building a culture of team, site and patient centricity. Helping Apogee become “Sponsor of Choice” with both our CRO partners and sites will be critical. This role is accountable for oversight of clinical monitoring activities from site identification through close out of the study site. The Clinical Monitoring Manager has ‘in-house’ responsibilities (e.g., oversight CRAs), and as required by project scope, sponsor monitoring or co-monitoring visits at the clinical study sites.

Job Responsibility

Oversee in-house Oversight CRAs that will oversee CRO CRA’s management of clinical study site activities for Apogee sponsored clinical trials
Serve as Apogee’s primary liaison with the in-house CRAs and CRO clinical monitoring team and liaise with clinical study sites
Accountable for oversight of clinical monitoring activities from site identification through close out of the study site
Responsible for the study deliverables of in-house CRAs on a given study(s)
May be responsible for the hiring of in-house CRAs
Input into and assist with the development of study documents
Oversee development and implementation of project specific processes, tools, and documents
Support the training and development of in-house CRAs
Oversight of review of monitoring visit reports and metrics
Responsible for oversight of CRA review of clinical data
Responsible for ensuring CRAs maintain their sites as inspection ready
Responsible for compiling and providing clinical monitoring metrics per KPIs
Lead, conduct, and document regular meetings with their in-house and CRO CRA team
Oversee the study specific performance of the CRA team(s)
Support and liaise with clinical site personnel, as needed
Review and approve time sheets and expense reports
Assist with review and revision of departmental SOPs and policies
Assist with creation and delivery of new department initiatives, improvement plans or training
May assist with the identification and selection of appropriate clinical trial sites and investigators
Conduct CRO co-monitoring visits or other monitoring visits as required by study needs
Oversee CRO site visits to qualify, initiate, and close-out study sites, and perform site monitoring
Review and ensure data integrity, accuracy, and completeness at the clinical study sites
Escalate site related issues to the study team
Oversee the coordination for study site audit and ensure assigned study sites are inspection-ready

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.

Nice to have

Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials
Certification as a Clinical Research Associate (CCRA) or equivalent

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
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

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