Site Monitoring LeadBedford, MAJob Type: ContractRecruiter: Hillary Bergstrom (https://digitalprospectors.com/our-team/hillary-bergstrom)Phone: 603-772-2700Position: Site Monitoring LeadLocation: Albany, NY (Remote – Local candidates preferred)Length: 12+ monthsJob Description:Our client is seeking a Site Monitoring Lead (SML) who will collaborate with the Lead Study Manager (LSM) to develop and implement a monitoring strategy for clinical studies. The SML will act as the primary point of contact for study-specific monitoring inquiries and will oversee Site Monitors (SMs) to ensure compliance with protocols, ICH-GCP, and applicable regulations. The SML will assist with site selection, monitor oversight, and risk management throughout the study lifecycle, from start-up to close-out.Essential Duties and Responsibilities (but not limited to):
Manage Site Monitors (SMs) for clinical study site activities, ensuring compliance with ICH-GCP, local regulations, and sponsor SOPs.
Provide oversight for monitoring consistency across study sites.
Support study start-up activities, including Site Qualification Visits (SQV) and Site Initiation Visits (SIV).
Work with CROs, monitors, and LSM to ensure timely site activation.
Collaborate with the LSM to develop and maintain monitoring and oversight plans, monitoring trackers, and study-specific tools (i.e., ISF reconciliation tool and SM FAQ).
Facilitate or support sites, monitor training sessions, SM meetings, and onboarding activities.
Review trip reports, track sites and monitor performance, and escalate risks to the LSM.
Assist with corrective and preventative actions related to site, SM, and vendor performance.
Support the LSM in managing regulatory documentation, including CDA, contract status, and site performance metrics.
Assist with line listing data reviews and updates to site-facing documents.
Co-monitor study sites when needed and assist with audits and inspections as required.
Build and maintain positive relationships with site teams, ensuring continuity throughout the study.
Promote effective communication with internal stakeholders and external study sites.
Qualifications:
Bachelor’s degree in a health or medical science field (or equivalent).
Minimum of 5 years of experience in clinical site monitoring within biopharmaceutical, pharmaceutical, or CRO environments.
Strong understanding of GCP and ICH guidelines and local regulatory requirements.
Proficiency in clinical documentation and Good Documentation Practices.
Excellent communication and conflict resolution skills.
Strong organizational, time management, and problem-solving abilities.
Proficient in Microsoft Office and clinical IT applications (ability to adapt to new technologies).
Ability to analyze sites and monitor metrics and implement corrective actions when needed.
Strong interpersonal skills with the ability to work effectively in a matrix environment.
Ability to manage multiple tasks and prioritize effectively in a fast-paced, changing environment.
Independent and accountable, with the ability to set a sense of urgency as needed.
Demonstrated leadership and decision-making capabilities in a clinical monitoring context.
Experience in managing or overseeing site monitors is preferred.
Experience in rare diseases, genetic disorders, and complex therapeutic areas (i.e., oncology, pediatric studies, neurology, cardiovascular, etc.) is preferred.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.Make this your next career move as one of our many long-term contractors or employees!
Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
Come see why DPC has achieved:
4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
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