Site Monitoring Lead

Summary:

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. The core duties and responsibilities include, but are not limited to:

Responsibilities:

•Responsible for study level management of SMs for clinical study site/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Clinical Monitoring Plan, and associated documents.

•Conduct study start up activities where applicable at the site level including but not limited to SQV, SIV (as applicable), including management of issues that may compromise time to site activation and/or initiation.

•Partners with CRO/monitor and Lead Study Manager (LSM) to ensure site activation and support site monitoring readiness in anticipation of first patient first visit.

•Support the LSM on monitoring oversight activities such as but not limited to monitor selection, site selection 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, ISF Reconciliation Tool and monitoring visit tracker).

•Facilitate and/or support the LSM with study wide SM trainings and SM meetings.

•Reviews trip reports, tracks, and escalates risks to LSM.

•Provide LSM with feedback on individual SM progress at sites.

•Support the LSM in the review, tracking and reporting of monitoring and start-up metrics (e.g., CDA and contract status, site and SM performance metrics).

•Co-monitoring as needed.

•May serve as SM at study sites depending on LSM delegation and/or study needs as applicable.

•Support LSM in audit/inspection activities as needed.

•Facilitates and/or supports remote and on-site monitoring activities, including training visits.

•Develops strong study team relationships with internal stakeholders.

•Promote positive site relationships and ensure continuity through all phases of the trial.

•Supports the LSM in reviews, and monitoring of required regulatory documentation for study start-up, study maintenance and study closeout.

•Supports LSM in risk and issue management, including development of corrective and preventative actions, relevant to site, SM, and vendor performance.

•Supports LSM in line listing data reviews and updating site-facing data management documents.

Requirements:

•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).

•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.