At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Summary of Job Description
- Review site activities through visits and off-site monitoring and contact to monitor study sites following the monitoring plan and the applicable BMS SOPs, to assure compliance with the protocol, ICH GCP guidelines and local regulations
- Prepare and submit written reports, both monitoring and administrative
- Interact and build professional and collaborative relationships with all study personnel and peers
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
Internal Stakeholders;
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
External Stakeholders;
Principal Investigator, Sub-Investigators, Study Coordinators, Research Nurses, Research Managers, Data Managers, Pharmacists, Ethics Committees , Vendors, MOH Personnel (where applicable), GCP Office (China only)
Requirements:
1. Bachelors degrees in Pharmacy or Health-related field, at least 3 years of site monitoring experience
2. Ability to manage multiple protocol across multiple therapeutic area, Knowledge of clinical trial conduct including HA requirements and ICH GCP
3. Good command of English communication, Excellent communication skills (written and verbal), Excellent organization skill
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.
