Clinical Trial Monitor

Bristol Myers Squibb4 LocationsonsiteSalary not postedView the original posting at Bristol Myers Squibb ↗

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.bms.com/working-with-us . 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. Position Responsibilities • 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, bo

The people who work here are one introduction away.

We show you who they are and write your first message — the insider list for this posting is filling in now. You have one introduction. The rest follows.

People at Bristol Myers Squibb you can reach out to

7 of 59 public LinkedIn profiles found in searches for Bristol Myers Squibb list Bristol Myers Squibb in their headline — those are the ones you can be confident work there. Pick who to reach out to — we'll draft your message; you make the contact. The rest, when shown, are marked Unverified.

Profiles are public pages as indexed by the search engine — we never log in to LinkedIn or copy private data, and anyone can ask to be removed. Ask to be removed →

Start the conversation More CRA jobs