SR Assoc Director, Site Management Lead (Hybrid/On-site)

Description

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, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Senior Associate Director (SAD) Site Management Lead will support the Executive Director Site Management & Monitoring to oversee US clinical programs effectively and efficiently across multiple therapeutic areas in full compliance with GCP/ICH, quality, safety of patients and business goals. The SR AD, Site Management Lead is responsible for forecasting and providing oversight of resources supporting US Clinical Trial Managers (CTMs)and managing the Site Enablement and IC teams. This role is responsible for resources and direct reports under the oversight of the SAD Site Management Lead are responsible for the Site Management and Regulatory Ethics Committee/Institutional Review Board (IRB) submissions, inclusive of trial participation and informed consent to ensure activities on clinical trials are completed in accordance to milestones, timelines and quality.

The SR AD, Site Management Lead is accountable for end-to-end site management including resource forecasting, on-boarding, and performance tracking for FSP/ISP staff across all US clinical programs across Therapeutic areas, i.e., Clinical Associates (CAs), Clinical Trial Operations Specialist (CTOS), Regulatory Start Up Specialist (RSUS), Informed Consent Specialist (ICS) Site Activation Manager (SAM), Establishes standards. This role collaborates with internal stakeholders to support the allocation of resources and coordination of all staffing decisions. The incumbent is responsible for providing direction and management for direct reports assigned Site Management activities supporting trials conducted within Therapeutic Area(s). The CD&O line manager is responsible for providing strong leadership that is aligned to the HPBU intent, Medicine and CD&O vision, strategies, goals, and operating model to ensure successful delivery (speed & value) of clinical trials in the team.

The line manager is responsible for the execution, delivery and oversight of high-quality clinical trials that meet pipeline commitments, specific scientific medical, and regulatory requirements in the team as well as responsible for team performance oversight and excellence. This role embraces innovative technologies, as well as creates and maintains a culture that drives empowerment, smart risk talking and one common CD&O identity.

Duties & Responsibilities

• Builds, develops and maintains close working relationships with Clinical Development & Operations (CD&O) functional groups, e.g., Legal, Ethics & Compliance and third-party vendors including CROs, IRBs to assure a closely coordinated program of activities based on common objectives and focusing on value, quality and operational efficiencies.
• Provides leadership and strategic direction to the Site Enablement Team.
• Maintains oversight of the trials at all stages of conduct to ensure operational vendor oversight;
• Ensures delivery of site management activities and regulatory document collection (review, and approval of site essential documents, including placement in relevant systems (e.g., Clinergize)) is executed per regulations, process and in accordance with business needs.
• Provides comprehensive oversight of all regulatory submissions to IRB across all trials and therapeutic areas.
• Identifies and communicates operational issues and trends across the portfolio of trials based on input from 3rd party vendor(s), Regulatory Start Up Specialists (RSUS), trial team, and/or IRB vendor.
• Implements corrective actions/process improvements inclusive of audit findings and CAPAs to maintain and enhance overall trial execution and quality; represents all site management and regulatory document activities across trial portfolio. Oversee external Site Management FSP/ISP resources ~ 100-150.
• Leads continuous improvement strategies within the Site Management group and identifies ways to streamline work processes to support quality improvement initiatives.  
• Leads and/or represents Site Management function as Subject Matter Expert (SME) on local/global working groups.
• Leads Site Management inspection readiness activities, participates in Sponsor Inspections and support research s