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78 Bristol-Myers Squibb Jobs
Clinical Trial Monitor
Bristol-Myers Squibb
posted 5hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Working with Us
Challenging
Meaningful
Life-changing
Those aren't words that are usually associated with a job
But working at Bristol Myers Squibb is anything but usual
Here, uniquely interesting work happens every day, in every department
From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it
You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity
Take your career farther than you thought possible
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
Read more careers
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Purpose/Objective of the job
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
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
support Ethics Committee submission, ICF review, collection of documents to/from site
support ensuring access to eDC and BMS / vendor systems is available for clinical trial site personnel
support equipment calibration and tracking
support preparation of Study Initiation Visit materials
support coordination and ensure database lock timelines are met as required locally
Qualification and Experience Bachelors degree required preferably within life sciences or equivalent
Clinical Trial Monitor 2-3 years of relevant clinical research experience, able to work independently
Employment Type: Full Time, Permanent
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based on 127 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Bristol-Myers Squibb Benefits
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