THE POSITION

As part of Clinical Development & Operations (CD&O) team the Site Monitoring Lead (SML) is a key member of global Clinical Trial Team nominated to a specific trial within the Evidence Network. SMLs are accountable for authoring the monitoring risk assessments and plans, 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.

The SML 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 contributes to the overall success and delivery of their assigned clinical trial(s)in all R/OPUs according to defined milestones and key performance indicators (e.g. Medicine Excellence KPIs -MedEx).

The SML is accountable for managing the 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 ensure inspection readiness at all times.

Responsibilities

• Trial Preparation:
• Plan trial quality and risk monitoring/ mitigation as part of the Trial Team
• Deliver Risk-based Site Monitoring approach and training for the trial. Accountable for the development of the operational Site Monitoring & Oversight plans
• Develop and provide appropriate training of Site Monitoring to Clinical Trial Managers (CT Manager) and Clinical Research Associates (CRA)
• Participate in development of trial level documents
• Behave as expert and consultant on Site management and monitoring topics
• Integrate patient/site level feedback to the documents ensuring design with a focus on the patient
• Participate in and contribute to global/regional and local Trial Team meetings, international/ regional / local Investigator Meetings
• Timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee)
• Facilitate communication and direction with CT Managers and CRO CRAs
  
• Trial Conduct:
• Monitor progress and oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct including adherence to ICH-GCP, and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans
• Including but not limited to:
• Issue management / oversight on trial level
• Pre-identification of important protocol deviations from site issues/deviations
• Continuous review, risk identification, evaluation/ analysis and communication on a trial level as applicable
• Maintain Risk-based Site Monitoring approach for the trial and update Site Monitoring plan and trial level documents
• Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits) according to plan, implement follow-up actions and escalation, as required
• Contribute to preparation and implementation of amendments to the trial level documents including training material updates/retraining as needed
• Facilitate communication and training related to site monitoring in the trial:
• Communication with CT Managers, CRAs, perform re- training etc
  
• Participate, prepare input and (co-)lead Trial Oversight Meetings (country and trial level) and contribute to the timely responses to questions from external and internal stakeholders (including Regulatory Authority/ Ethics Committee)
  
  
• Trial Close-out:
• Coordinate timely cleaning and delivery of clinical trial data with Trial Team and countries
• Support compilation and review of the quality section for the clinical trial report for site monitoring activities
  
• 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” globally
• Can act as a mentor supervising developing Site Monitoring Lead(s)in other R/OPUs
• Participate in working groups related to site monitoring within the global functional team.
  
• Foster a learning culture in CD&O regions by encouraging continues learning, sharing best practices, learn from failures
• Embraces innovative technologies, as well as creates and maintains a culture that drives empowerment, smart risk taking and one common CD&O identity
  
  

This position is fully remote.

Employees in remote roles can live anywhere in Canada and are only required to visit the Burlington office a few times each year.

Requirements

• University or comparable degree in life sciences or related field OR several years of equivalent professional education may be acceptable if complemented by solid knowledge in and experience with Site Monitoring and Site Management processes and accountabilities
• Language: Fluent in English (written and spoken)
• Strong Communication Skills: Demonstrates Our Behaviors in complex cross-functional matrix structures of the trial and extended team. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Demonstrates active listening skills and cultural awareness
• Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors
• Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations, confidently coordinating and overseeing teams. Demonstrates leadership behaviors of supporting, connecting and empowering teams, setting priorities
  
  
  

Total Rewards

We offer a competitive salary, generous amount of paid time off (vacation, personal days, contingency paid time off days for Long Term Contract Employees), comprehensive and flexible benefits plan, Defined Contribution Pension Plan with company matching of RRSPs, Employee and Family Assistance Plan, employee and leadership development programs, and programs to support overall health and wellness for employees.

Visit https://www.boehringer-ingelheim.com/ca/careers/benefits-rewards

READY TO APPLY?

Click the "Apply Now" button below to submit your application.

We thank all applicants for their interest in our company. Please note that only candidates selected for an interview will be contacted.

Boehringer Ingelheim Canada is committed to providing accommodations for people with disabilities to support their participation in all aspects of the recruitment and selection process. If you require accommodation, we will work with you to meet your needs.

DEADLINE FOR APPLICATIONS

Applications for this position will be accepted until April 9, 2025

Not exactly the position you are looking for but have someone else in mind? Share it via the button on the bottom of the page with friends or colleagues who might be interested.

Our Company

At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.

Why Boehringer Ingelheim?

With us, you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.

Want to learn more? Visit https://www.boehringer-ingelheim.com