Site Monitoring Lead

Innova Solutions•Austin, NY

12d•Remote

About The Position

Innova Solutions has a client that is immediately hiring for a Site Monitoring Lead. This is a Full Time Contract position with a duration of 12 months, located remotely. As a Site Monitoring Lead, you will partner 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 monitoring team. You will support the LSM in development, adherence and oversight to the monitoring strategy and will escalate issues as applicable. You will, where assigned, oversee Site Monitors (SM), ensuring consistency across a study for monitor training, monitor report review, monitoring oversight, and overall site monitor activities.

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.
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.
May require 25-75% travel.

Nice To Haves

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.

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.
Partners with CRO/monitor and 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, report reviews 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 and/or support the LSM with the SM study-specific training plan and SM meetings.
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.