Site Monitoring Lead

Site Monitoring LeadPosition type: Full Time ContractDuration: 12 monthsContract Location: RemoteRole Responsibilities SummaryThe 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 monitoring team. The SML will support the LSM in development, adherence and oversight to the monitoring strategy and will elevate 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.ResponsibilitiesResponsible 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.RequirementsBA/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.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.Pay Range and BenefitsPay Range*: $50- - $55 per hour*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.BenefitsMedical & pharmacy coverageDental/vision insurance401(k)Health saving account (HSA) and Flexible spending account (FSA)Life InsurancePet InsuranceShort term and Long term DisabilityAccident & Critical illness coveragePre-paid legal & ID theft protectionSick timeOther types of paid leaves (as required by law)Employee Assistance Program (EAP)About Innova SolutionsFounded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.Recent RecognitionsNamed One of America's Best Employers for New Grads by Forbes (2024Named One of the Best Companies to Work for by U.S. News & World Report (Private Companies List, 2024-2025)One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)AWS Advanced Tier Services Partner with 100+ certificationsWebsite: Employment Opportunity StatementsInnova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment.Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [View email address on click.appcast.io] or View phone number on click.appcast.io. Please indicate the specifics of the assistance needed.Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities.Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.J-18808-Ljbffr Innova Solutions Inc