Associate Director, Monitoring Oversight Management Job at Apogee Therapeutics

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

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Associate Director, Monitoring Oversight Management

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