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Associate Director, Monitoring Oversight Management

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Apogee Therapeutics

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Location:
United States

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

180000.00 - 205000.00 USD / Year
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Job Description:

We are seeking an Associator 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.

Job Responsibility:

  • Manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities for Apogee sponsored clinical trials
  • Support contract Oversight CRAs globally
  • Serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs
  • Contribute to building a culture of team, site and patient centricity
  • Contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies
  • Leadership of Oversight CRAs globally driving the team to ensure study deliverables are met with efficiency and quality
  • Responsible for hiring in-house Oversight CRAs
  • Assist with creation, review and revision of departmental SOPs and policies
  • Lead, conduct, and document regular meetings with Oversight CRA team and with individual CRAs
  • Assist with creation and delivery of department initiatives, improvement plans and/or training
  • Create SOPs and process to support the responsibilities of the monitoring excellence organization
  • Responsible for the training and development of in-house Oversight CRAs and ensuring training compliance is maintained
  • Contribute to development and implementation of risk-based monitoring strategies
  • Assist monitoring head with resourcing/capacity management projections
  • 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
  • Create and implement monitoring processes, tools, and documents
  • Periodic review of monitoring visit reports and metrics
  • Responsible for ensuring Oversight CRAs maintain their sites as inspection ready, including the Trial Master File (TMF)
  • Responsible for compiling and providing clinical monitoring metrics per KPIs
  • Support and liaise with clinical site personnel
  • Review and approve time sheets and expense reports
  • Conduct periodic quality visits for Senior Oversight CRAs
  • Ensure all site oversight visits are completed within the expected timelines globally
  • Oversee all timelines and KPIs for the oversight monitoring team globally
  • Ensure the oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites

Requirements:

  • 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 can also work independently without significant oversight
  • 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 mandatory in-person attendance at Apogee All Hands meetings typically held twice per year, and a clinical operations meeting held once 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

Additional Information:

Job Posted:
January 03, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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