Clinical Trial Monitor

6 maanden geleden

Utrecht, Nederland Bristol-Myers Squibb Voltijd

**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.

**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
- Recommends sites during the site feasibility and/or site selection process
- Conducts Investigator Site assessment 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 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 requires travel.
- 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 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

**Experience Requirements**
- Bachelor's degree required preferably within life sciences or equivalent. Valid driver's license.
- Clinical Trial Monitor: 2-3 years of relevant clinical research experience, able to work independently.
- Native Dutch speaker with good verbal and written communication skills (both in English and local language).
- Has basic to good knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials.
- Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management.
- Organization and time management skills.
- Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations.

**Uniquely Interesting Work, Life-changing Careers**

**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 ess

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