Clinical Monitoring Manager

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq‑listed company that offers the opportunity to work in a fast‑paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well‑established mechanisms of action and incorporating advanced antibody engineering to optimize half‑life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”

We are a fast‑paced company committed to building an exceptional company culture, founded on our C.O.R.E. values:
Caring, Original, Resilient and Egoless.

If this sounds like you, keep reading!

We are seeking a Clinical Monitoring Manager to oversee in‑house Oversight CRAs that will manage CRO CRA’s oversight of clinical study site activities for Apogee‑sponsored clinical trials. This role will also 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 to contribute to a culture of patient centricity.

The manager will be accountable for oversight of clinical monitoring activities from site identification through close‑out, and may also conduct sponsor monitoring or co‑monitoring visits at study sites as required.

In‑house responsibilities:

• Ensure study deliverables of in‑house CRAs are met with efficiency and quality, in accordance with SOPs, regulations, GCP, KPIs, and study‑specific requirements.
• May be responsible for hiring of in‑house CRAs.
• Assist in development of study documents (protocols, case report forms, informed consent forms).
• Oversee development and implementation of project‐specific processes, tools, and documents (monitoring oversight plans, site visit report templates, monitoring tools).
• Support training and development of in‑house CRAs and ensure training compliance.
• Collaborate with the study team on best practices, quality by design and operational delivery.
• Oversee review of monitoring visit reports and metrics, summarize for the study team, and develop corrective and preventative actions as needed.
• Ensure CRAs manage their site’s data with quality and integrity.
• Maintain CRAs’ sites as inspection‑ready, including the TMF for health authority inspections.
• Compile and provide clinical monitoring metrics per KPIs.
• Lead, conduct, and document regular meetings with the CRA team and individual CRAs.
• Oversee the CRA team’s performance and implement action plans; escalate issues to the Executive Director, Clinical Operations.
• 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 selection of appropriate clinical trial sites and investigators.

Field monitoring responsibilities:

• Conduct CRO co‑monitoring visits or other monitoring visits (site qualification, initiation, interim monitoring, or close‑out) as required.
• Oversee CRO site visits to ensure compliance with study timelines, protocol requirements, and regulatory guidelines.
• Review data integrity, accuracy, and completeness at the clinical study sites.
• Escalate site‑related issues to the study team.
• Oversee coordination for site audit and make sites inspection‑ready as needed.

• Bachelor's degree in a scientific or healthcare‑related field.
• Minimum of 8 years of experience as a CRA or related role within pharmaceuticals, biotechnology, or medical…