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As part of Clinical Development & Operations (CD&O) team the Site Monitoring Lead Local (SML-l) is a key member of the local Clinical Trial Team assigned to a specific trial(s). The ideal candidate will have previous leadership and monitoring experience within the therapeutic area of Oncology. SML-ls are accountable for ensuring sponsor oversight, trend analysis, signal detection and delivery of their assigned trial(s) in close collaboration with the CRO partner to ensure delivery of BI’s pipeline through accurate planning and efficient execution of Site Monitoring in trials that bring speed & value to participating subjects and sites. This role represents the Monitoring function on US clinical trial teams and direct the efforts of CRAs to monitor US clinical programs effectively and efficiently across multiple therapeutic areas in full compliance with GCP & ICH, quality, safety of patients, data integrity and business goals. The SML-l provides Site Monitoring expertise to and consults the Trial Team, leads and oversees the implementation of the Site Monitoring & Oversight approach and activities as part of overall clinical trial quality management. SML-l contributes to the overall success and delivery of their assigned clinical trial(s)in the R/OPU according to defined milestones and key performance indicators (e.g., Medicine Excellence KPIs -MedEx). The SML-l is accountable for managing the local trial level planning, implementation, issue management, and oversight of the Site Monitoring activities of a trial as assigned, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, BI sponsor obligations, ICH-GCP and applicable regulations and always ensuring inspection readiness.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Trial Preparation:
Trial Conduct:
Trial Close-out:
Coordinate timely cleaning and delivery of clinical trial data within OPU
Leadership Competencies:
Creates an environment that inspires, motivates, and empowers colleagues and promotes one common CD&O identity, contributing to acceleration of clinical development timelines and value creation for patients.
Can act as an established Subject Matter Expert A (SME) in the “SME network” locally/globally
Can act as a mentor supervising developing Site Monitoring Leads - Locals (SML-l) at OPU.
Participate in working groups related to site monitoring within the local functional team.
This position offers a base salary typically between $111,000 and $183,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.
Full Time
$108k-141k (estimate)
05/23/2024
07/21/2024