Site Monitoring Lead II

Company: Innova Solutions
Location: Atlanta
Posted on: April 15, 2024

Job Description:

Innova Solutions is immediately hiring for a Site Monitoring Lead IIPosition type: Full-time ContractDuration: 8 monthsLocation: RemoteAs a Site Monitoring Lead II you will:JOB DESCRIPTIONPosition 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, as assigned:

• 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.Behavioral Competency Expectations:
    • 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.Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.Thank you!Preeti Sehgalpreeti.sehgal@innovasolutionscom PAY RANGE AND BENEFITS:Pay Range*: $75 - $79/hr depending on experience *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. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).ABOUT INNOVA SOLUTIONS: Founded 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 Recognitions:
      • One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
      • ClearlyRated - Client Diamond Award Winner (2020)
      • One of the Largest Certified MBE Companies in the NMSDC Network (2022)
      • Advanced Tier Services partner with AWS and Gold with MSWebsite: Innova 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 or (770) 493-5588. 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.American Cybersystems, Inc is acting as an Employment Agency in relation to this vacancy.

Keywords: Innova Solutions, Redan , Site Monitoring Lead II, Other , Atlanta, Georgia