Associate Director, Monitoring Oversight Management @Apogee Therapeutics

[Hiring] Associate Director, Monitoring Oversight Management @Apogee Therapeutics

Mar 26, 2025 - Apogee Therapeutics is hiring a remote Associate Director, Monitoring Oversight Management. 💸 Salary: $170,000 - $195,000 per year. 📍Location: USA.

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Role Description

We are seeking an Associate Director, Monitoring Oversight Management to manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities for Apogee sponsored clinical trials. This role will also support contract Oversight CRAs globally. In this role, you will serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs 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 will also contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies.

Key Responsibilities

Leadership of Oversight CRAs globally to ensure study deliverables are met with efficiency and quality.
Responsible for hiring of in-house Oversight CRAs.
Contribute to development and implementation of risk-based monitoring strategies.
Assist monitoring head with resourcing/capacity management projections across clinical studies and/or therapeutic areas.
Contribute to overall operational readiness to support clinical operations monitoring oversight activities.
Facilitate resolution of region specific and site management related challenges.
Communication and issue resolution with clinical vendors, as needed.
Create and implement monitoring processes, tools, and documents (e.g., monitoring oversight plan, site visit report templates).
Responsible for the training and development of in-house Oversight CRAs and ensuring training compliance is maintained.
Periodic review of monitoring visit reports and metrics, as applicable.
Ensure Oversight CRAs maintain their sites as inspection ready, including the Trial Master File (TMF).
Compile and provide clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities.
Lead, conduct, and document regular meetings with Oversight CRA team and individual CRAs.
Support and liaise with clinical site personnel, as needed.
Review and approve time sheets and expense reports.
Assist with creation, review and revision of departmental SOPs and policies, as applicable.
Assist with creation and delivery of department initiatives, improvement plans and/or training.
Conduct periodic quality visits for Senior Oversight CRAs, as needed.
Ensure all site oversight visits are completed within the expected timelines globally.
Oversee all timelines and KPIs for the oversight monitoring team globally.
Ensure oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites.

Qualifications

Bachelor's degree in a scientific or healthcare-related field.
Minimum of 8-10 years of experience as a CRA or related role within the pharmaceutical or biotechnology industry.
Minimum 5 years of experience leading a team of CRAs.
Recent experience working on respiratory, dermatology and/or gastrointestinal clinical trials preferred.
Experience working in Phase I – III clinical trials.
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 and independently.
Experience working in a fast-paced and dynamic environment.
Certification as a Clinical Research Associate (CCRA) or equivalent preferred.
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless.
Position requires up to 35% travel including to company meetings at least twice per year.

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.
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
Flexible PTO.
Two, one-week company-wide shutdowns each year.
Commitment to growing you professionally and providing access to resources to further your development.
Regular all team, in-person meetings to build relationships and problem solve.

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Associate Director, Monitoring Oversight Management @Apogee Therapeutics

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Salary 💸 $170,000 - $195,000 per year	Remote Location USA
Job Type unspecified	Posted Mar 26, 2025

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[Hiring] Associate Director, Monitoring Oversight Management @Apogee Therapeutics

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