Clinical Trial Monitor

**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. Take your career farther than you thought possible.

Bristol Myers Squibb es un empleador que brinda igualdad de oportunidades. Las personas que apliquen para cualquier vacante, y que estén calificadas para la misma recibirán consideración para el empleo sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, nacionalidad, edad, discapacidad, condición de veterano protegido, embarazo, ciudadanía, estado civil, expresión de género, información genética, afiliación política o cualquier otra característica protegida por la ley.

**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**

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
- Perform Unblinded Site Monitor activities to protect the blind of the study b y 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

**Degree**Requirements**

Bachelors or Master's degree required

Field of study within life sciences o r equivalent Valid driver's license (as locally required)

**Experience**Requirements**
- Associate Clinical Trial Monitor: 1 year of relevant clinical research experience and/or relevant educational experience
- Clinical Trial Monitor: 2-3 years of relevant clinical research experience, able to work independently.
- Senior Clinical Trial Monitor: A t least 5 years of monitoring experience. Demonstrate leadership skill, mentor and coach capability
- Relevant