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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Senior Site Monitoring Lead
Remote, TX US
Posted: 06/10/2025
2025-06-10
2025-07-15
Employment Type:
Contract
Job Category: Operations and Development
Job Number: 4498
Job Description
The Senior Site Monitoring Lead (SML) is responsible for partnering with the Lead Study Manager (LSM) to develop the monitoring strategy for the study and will be the primary point of contact for study-specific questions from both the internal and where applicable CRO team for monitoring.
The SML will support the LSM in development, adherence and oversight to the monitoring strategy and will escalate issues as applicable. The SML, where assigned, will oversee Site Monitors (SM), ensuring consistency across a study for monitor training, monitor report review, monitoring oversight, and overall site monitor activities.
Responsibilities:
The SML will support the LSM in development, adherence and oversight to the monitoring strategy and will escalate issues as applicable. The SML, where assigned, will oversee Site Monitors (SM), ensuring consistency across a study for monitor training, monitor report review, monitoring oversight, and overall site monitor activities.
Responsibilities:
- Responsible for study level management of SMs for clinical study site/monitoring activities in compliance with ICH-GCP, SOPs, if applicable, Protocol, Clinical Monitoring Plan, and associated documents.
- Support the LSM on monitoring oversight activities such as but not limited to monitor selection, report reviews, conduct of Monitoring Oversight Visits, review of monitoring metrics and other monitoring oversight activities as applicable.
- Assist LSM with creating and maintaining monitoring and/or monitoring oversight plans and study specific tools/trackers (e.g., SM FAQ and ISF Reconciliation Tool.
- Facilitate the SM study-specific training plan, SM meetings and provide training.
- May serve as on-site or remote SM, co-monitor at study sites depending on LSM delegation and/or study or CTBO department needs as applicable.
- Supports LSM in audit/inspection activities and risk and issue management, including development of corrective and preventative actions, relevant to site, SM, and vendor performance.
- Conduct visits on behalf of the Site Monitoring and Management team such as monitoring, monitoring oversight and/or training visits, as needed.
- BA/BS required, with preference for BA/BS with strong emphasis in health or medical
science or equivalent. - Minimum of 5 years required of direct site monitoring experience in a Biopharmaceutical, Pharmaceutical or CRO company, or equivalent.
- Prior experience in oversight or management of site monitors, management of global
teams is preferred. - Experience monitoring rare and ultra-rare disease, genetic disease preferred.
- Monitoring metabolic disease, pediatric studies, complex therapeutic studies such as
Oncology, Cardiovascular, Infectious Disease, Neurology, Transplant, etc. is a plus. - Fluent in English and local languages where applicable (verbal and written) and excellent
communication skills and strong aptitude for conflict resolution. - Strong knowledge of GCP/ICH requirements, and ability to work within country regulatory requirements and guidelines, as applicable.
- Knowledge and application of Good Documentation Practices.
- Ability to conduct assessment of site performance and implement effective corrective actions.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Proficient IT skills (Use of MS Office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices.
- Ability to analyze data/metrics and act appropriately.
- 25% travel may be required and valid driver’s license.
- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
- Works independently with high sense of accountability.
- Ability to create and modulate sense of urgency when needed and as appropriate.
- Ability to set priorities and handle multiple tasks in a changing environment.
- Works effectively in a matrix environment.
- Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates high quality and compliance mindset.