Senior Clinical Trial Monitor; Kentucky

Position: Senior Clinical Trial Monitor (Kentucky)
Location: Benton

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:

Position Summary

The Senior Clinical Trial Monitor is responsible for overseeing clinical trials, ensuring that they are conducted, recorded, and reported in compliance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The role acts as a point of contact at the site level for both internal and external stakeholders.

This position will reside in Kentucky.

Position Responsibilities:

* Identify new potential investigators and assess their sites for clinical trial capabilities.

* Build relationships with sites, including management of Contract Research Organizations (CROs).

* Recommend sites during feasibility and selection processes.

* Conduct pre-study and initiation visits to train site personnel.

* Monitor site activities through visits, ensuring adherence to protocols and regulations.

* Serve as an unblinded site monitor to protect study integrity.

* Use data to assess risks, identify issues, and make informed decisions.

* Provide training to site staff and manage site closure activities.

* Oversee site personnel to meet study objectives, including enrollment and retention goals.

* Address and escalate issues, ensuring corrective actions are implemented.

* Prepare and submit reports and support regulatory audits and inspections as needed.

Senior Level Expectations:

* Proactively identify and resolve issues at both site and country levels.

* Collaborate with Clinical Trial Managers to address complex issues.

* Serve as a mentor and coach, providing guidance and training to team members.

* May be assigned as a Lead Clinical Trial Monitor for a study locally.

Degree Requirements:

* Bachelor's degree, preferably in life sciences or equivalent.

* Valid driver's license (as required).

Experience Requirements:

* Minimum of 5 years of experience in clinical research or related fields.

* Candidates must be located in Kentucky.

Key

Competencies:

* Knowledge of ICH/GCP guidelines and local regulations.

* Strong clinical research understanding.

* Excellent organization, time management, and communication skills.

* Proficiency in Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Data Capture Systems (eDC), and Electronic Trial Master File (eTMF).

Travel Requirements:

* Travel up to 30%, depending on workload and region needs, may include air travel and overnight stays.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace…