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Apogee Therapeutics · 6 days ago

Associate Director, Monitoring Oversight Management

United States

Contract

Hybrid

Lead/Staff, Director/Executive

$180K/yr - $205K/yr

8+ years exp

Apogee Therapeutics is a biotechnology company focused on developing differentiated biologics for various inflammatory and immune diseases. The Associate Director, Monitoring Oversight Management will manage Oversight CRAs, ensuring the efficiency and quality of clinical trial monitoring and site management activities, while contributing to process development and risk-based monitoring strategies.

BiotechnologyLife ScienceMedicalTherapeutics

H1B Sponsor Likely

Responsibilities

The Associate Director of Monitoring Oversight Management is responsible for the leadership of Oversight CRAs globally driving the team to ensure study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements

Responsible for hiring in-house Oversight CRAs

Assist with creation, review and revision of departmental SOPs and policies, as applicable

Lead, conduct, and document regular meetings with Oversight CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency

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 across clinical studies and/or therapeutic areas

Contribute to overall operational readiness to support clinical operations monitoring oversight activities across studies and/or therapeutic areas

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, monitoring tools)

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

Responsible for ensuring Oversight CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections

Responsible for compiling and providing clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities

Support and liaise with clinical site personnel, as needed

Review and approve time sheets and expense reports

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 the oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites

Qualification

Clinical trial managementRisk-based monitoringGCP knowledgeTeam leadershipMicrosoft Office SuiteEDC systemsClinical trial processesCaringOriginalResilientEgoless valuesTrainingDevelopmentEffective communicationOrganizational skillsInterpersonal skillsFast-paced environment experienceTime managementProblem-solving

Required

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

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

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

Preferred

Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials preferred

Certification as a Clinical Research Associate (CCRA) or equivalent preferred

Benefits

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

We provide competitive time off, including 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

Company

Apogee Therapeutics

Apogee Therapeutics is a biotechnology company that offers therapies for immunological and inflammatory disorders.

Founded in 2022

San Francisco, California, USA

201-500 employees

https://apogeetherapeutics.com/

H1B Sponsorship

Apogee Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (3)