Clinical Site Monitor

Profile

Job Information
Bristol Myers Squibb
Clinical Site Monitor
in
Princeton
New Jersey
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Summary - Position to be located in NY/NJ with easy of access to Manhattan. 10-20% travel required outside of assigned territory. Responsibilities include but not limited to: identifies new investigators, assesses potential investigator and their sites, develops site relationships, recommends site during the site selection process, conducts pre-study visits and subsequent monitoring visits for training purposes and to ensure safety and protection of study subjects, reviews site activities and quality through on site and off site visits. Must demonstrate the ability to sue data to assess risks, identify issues and make appropriate decisions. Serve as point of contact for sites. manage multiple protocols across therapeutic areas which may require travel based on assigned site location and/or geographic territory.
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
Requirements
Bachelors degrees, preferably in life scni
2-3 years of relevant clinical research experience, able to work independently.
Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred
Experience in the drug discovery/development process.
Key Competencies
Has basic to good knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials. ​
Knowledge and understanding of clinical research processes, regulations and methodology
Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management​
Organization and time management skills.
Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations
Good verbal and written communication skills (both in English and local language).
Microsoft Suite
Clinical Trial Management Systems (CTMS)
Electronic Data Capture Systems (eDC)
Electronic Trial Master File (eTMF)
Metrics Websites
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 the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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