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Bristol-Myers Squibb

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4.1

based on 120 Reviews

67 Bristol-Myers Squibb Jobs

Clinical Trial Monitor

BRISTOL-MYERS SQUIBB INDIA PVT.LTD.

4.1

based on 120 Reviews

1-4 years

Mumbai

1 vacancy

Clinical Trial Monitor

Bristol-Myers Squibb

posted 14d ago

Job Role Insights

Flexible timing

Key skills for the job

Excel Hospital Administration Research Auditing Recruitment Life Sciences

+ 4 more

Job Description

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.

accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

Employment Type: Full Time, Permanent

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