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Senior Clinical Trial Monitor
Regional Clinical Operations Canada
Functional Area Description
Research & Development
Position Summary / Objective
Responsible for the oversight of the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
Act as one of the points of contact at a Site level for internal and external stakeholders
Key Responsibilities and Major Duties
Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders.
Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.
Develop Site relationships (incl. Contract Research Organization related issue management and non- registrational /Investigator Sponsored Research Studies)
Recommends sites during the site feasibility and/or site selection process
Conducts pre-study visit as appropriate
Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation
Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, BMS procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable
Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.
While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions.
Serve as a point of contact for Sites
Provides trainings to sites
Performs site closure activities when all required protocol visits and follow-up are completed
Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
Ensures completeness and quality of data submitted from study sites. Ensures eCRF data is available and current by using the available systems to follow site activities.
Oversees activities of site personnel over whom there is no direct authority.
Motivates/influences the site to meet study objectives, including enrolment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method
Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented
Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions
Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
May support Ethics Committee submission, ICF review, collection of documents to/from site
May support ensuring access to eDC and BMS / vendor systems is available for clinical trial site personnel
May support equipment calibration and tracking
May support preparation of Study Initiation Visit materials
May support coordination and ensure database lock timelines are met as required locally
Senior Level Expectations:
Proactively identify and resolve potential problems at both site and country level.
Engage with Clinical Trial Manager and/or line management to assist in the resolution of more complex issues.
Proactively seek to enhance communication skills with both internal (Global level) and all relevant external parties and coaches others to do the same.
Contribute significantly to study team and coaches site staff to enhance site and hub performance.
Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations.
May assist line management with conducting monitoring authorizations and ongoing assessments
Key Stakeholders/Contacts - describe this position's key internal matrix relationships and key external stakeholders/clients
Medical Monitor (MM), Protocol Manager (PTM), Clinical Trial Leads, Clinical Trial Associates (CTA), Site Relationship Managers, Study Start-up Specialists, Site Contract Leads, Vendor Operations Managers, Regional Clinical Compliance Leads, Central Data Reviewer (CDR), Data Management Leads, Line Managers(LM), Head, Clinical Operations , local Regulatory and local Medical Affairs team
Principal Investigator, Sub-Investigators, Study Coordinators, Research Nurses, Research Managers, Data Managers, Pharmacists, Ethics Committees , Vendors.
Bachelors or Master's degree required
Field of study within life sciences or equivalent
Valid driver's license (as locally required)
Associate Clinical Trial Monitor: 1 year of relevant clinical research experienceand/or relevant educational experience
Clinical Trial Monitor: 2-3 years of relevant clinical research experience, able towork independently.
Senior Clinical Trial Monitor: At least 5 years of monitoring experience.Demonstrate leadership skill, mentor and coach capability
Relevant prior Pharma/Biotech Sponsor employment or experience as aclinical study coordinator preferred
Experience in the drug discovery/development process.
Key Competency Requirements
Has basic to good knowledge of ICH/GCP Guidelines and applicable local lawsand regulations (Health Authorities) which govern clinical trials.
Knowledge and understanding of clinical research processes, regulations andmethodology
Understands clinical landscape with practical knowledge of a variety of medicalsettings and medical records management
Organization and time management skills.
Ability to build, maintain and strengthen relationships even under pressureand/ or in difficult situations
Good verbal and written communication skills (both in English and locallanguage).
Clinical Trial Management Systems (CTMS)
Electronic Data Capture Systems (eDC)
Electronic Trial Master File (eTMF)
Travel required, mostly within Quebec and Ontario; varies based on country need
Overnight Absences Required (per typical month)
1-2 overnight absence per month; varies based on country need
Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment
Ergonomic (as applicable)
Remote by design (as applicable)
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.