What are the responsibilities and job description for the Clinical Trial Site Management Lead position at Randstad Life Sciences US?
About the Company
A major company that creates new ways to measure and improve health in everyday life—making proactive, personalized, and truly human-centered healthcare possible. By connecting directly with millions of individuals, Harnesses real-world data to deeply understand health experiences, rapidly and at scale. Company's privacy-centric digital health measurement and engagement platform uses data science and machine learning to translate these everyday insights into high-impact health guidance, treatments, and tools. The company is headquartered in California with employees working around the globe.
We are seeking a highly motivated and experienced Clinical Trial Manager (CTM) with a focus on site management to join our dynamic team. The CTM will play a critical role in overseeing and coordinating clinical trial activities, ensuring that study sites operate efficiently, comply with all regulatory requirements, and meet enrollment and data collection goals. This individual will work closely with cross-functional teams, external vendors, and clinical sites to drive the successful execution of Company's innovative, decentralized, patient-centered research programs.
EXPERIENCE WITH BELOW STRONGLY DESIRED :
Decentralized Trials
Patient-generated health data
Responsibilities
Oversee site qualification, selection, activation, monitoring, and closeout activities to ensure compliance with study protocols, GCP, and regulatory requirements.
Develop and manage site management plans, including timelines, resource allocation, and budgets; ensuring all related activities align with study protocol and regulatory standards.
Train site personnel on study protocols, procedures, and digital tools to ensure compliance and alignment with study objectives.
Track site performance metrics, including recruitment, retention, and data quality, and develop strategies to address challenges.
Collaborate with internal teams to ensure seamless execution of trial activities.
Identify and resolve data discrepancies and protocol deviations promptly, working collaboratively with site personnel.
Prepare comprehensive monitoring reports documenting observations, findings, and recommendations for corrective actions.
Ensure that all site-related documentation, including regulatory submissions, site communications, and monitoring reports, is accurate, complete, and timely.
Maintain effective communication with Investigators, Study Coordinators, and other stakeholders to ensure smooth study conduct.
Contribute to risk assessments and participate in the development of risk mitigation strategies.
Prepare for and participate in regulatory inspections and audits.
Stay up-to-date on current GCP guidelines, regulatory requirements, and clinical trial best practices.
Qualifications
Minimum of 5 years of experience as a CTM with a demonstrated focus on management of multiple clinical sites
Strong understanding of GCP principles, ICH guidelines, and relevant regulatory requirements for clinical research.
Excellent organizational skills, attention to detail, and the ability to identify and resolve discrepancies.
Excellent communication, interpersonal, and problem-solving skills.
Experience working on decentralized research and / or observational studies preferred.
Familiarity with digital health technologies and patient-generated health data
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