Original listing text, shown exactly as published by the company.
Key Responsibilities
In-house 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
Field management responsibilities
- 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
Ideal Candidate
- 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
The anticipated salary range for candidates for this role will be $180,000-$205,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
