Huidige banen gerelateerd aan Clinical Trial Monitor - Utrecht, Utrecht - Bristol-Myers Squibb
-
Clinical Trial Operations Specialist
2 weken geleden
Utrecht, Utrecht, Nederland Bristol Myers Squibb VoltijdJob SummaryBristol Myers Squibb is seeking a highly skilled Clinical Trial Monitor to join our team. As a Clinical Trial Monitor, you will be responsible for ensuring the smooth conduct of clinical trials at investigator sites. This includes identifying and assessing potential investigators, developing site relationships, and conducting monitoring activities...
-
Clinical Trial Planning Manager
1 week geleden
Utrecht, Utrecht, Nederland Genmab VoltijdAbout the RoleWe are seeking a highly skilled Clinical Trial Planning Manager to join our Development Program Management team at Genmab. As a key member of our global Portfolio & Project Management department, you will play a pivotal role in advancing transformative therapies to patients.Key ResponsibilitiesDevelop and execute comprehensive clinical trial...
-
Clinical Research Associate
6 dagen geleden
Utrecht, Utrecht, Nederland HKU VoltijdClinical Research AssociateThe Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under the LKS Faculty of Medicine. We are seeking a highly skilled Clinical Research Associate to join our Project Operations Unit (POU) and contribute to the planning, initiation, and monitoring of clinical studies.Main...
-
Clinical Trial Disclosure Manager
2 weken geleden
Utrecht, Utrecht, Nederland Genmab VoltijdPosition OverviewAt Genmab, we are dedicated to ensuring transparency in clinical research. We understand the scientific and ethical importance of sharing clinical trial data in a timely and unbiased manner to benefit patients and stakeholders alike. The Clinical Trial Disclosure & Transparency (CTD&T) team operates within Development Operations, which...
-
Clinical Trial Disclosure Manager
2 weken geleden
Utrecht, Utrecht, Nederland Genmab VoltijdPosition OverviewAt Genmab, we prioritize the transparency of clinical research. We understand the scientific and ethical importance of disseminating clinical trial information in an unbiased and timely manner to benefit patients and other stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team operates within Development Operations, which...
-
Manager of Clinical Trial Transparency
2 weken geleden
Utrecht, Utrecht, Nederland Genmab VoltijdAbout the RoleGenmab is seeking a highly skilled and experienced Manager to join our Clinical Trial Disclosure & Transparency team. As a key member of our Development Operations team, you will play a critical role in ensuring the transparent disclosure of clinical trial information across our global portfolio.Key ResponsibilitiesPublic Disclosure Management:...
-
Senior Clinical Trial Associate
2 weken geleden
Utrecht, Utrecht, Nederland Genmab VoltijdAbout the RoleThe Senior Clinical Trial Associate will play a key role in ensuring the success of clinical trials at Genmab. This position will be responsible for overseeing the filing of documents to ensure inspection readiness and supporting the Clinical Trial Manager/Team with key administrative activities.Key ResponsibilitieseTMF Management:Set up,...
-
Clinical Trial Disclosure Manager
2 weken geleden
Utrecht, Utrecht, Nederland Genmab VoltijdAbout the RoleGenmab is seeking a highly skilled and experienced Manager to join our Clinical Trial Disclosure & Transparency team. As a key member of our Development Operations team, you will play a critical role in ensuring the transparency and disclosure of clinical trial information across our global portfolio.Key ResponsibilitiesPublic Disclosure...
-
Associate Director, Clinical Trial Associate Manager
2 weken geleden
Utrecht, Utrecht, Nederland Genmab VoltijdAbout the RoleWe are seeking a highly skilled and experienced Associate Director, Clinical Trial Associate to join our team at Genmab. As a key member of our Trial Strategy and Delivery department, you will be responsible for managing a team of Clinical Trial Associates (CTAs) and providing strategic direction to support the success of our clinical...
-
Clinical Trial Disclosure Manager
2 weken geleden
Utrecht, Utrecht, Nederland Genmab VoltijdPosition OverviewAt Genmab, we are dedicated to the transparent dissemination of clinical trial information. We understand the critical importance of sharing clinical trial data in a timely and unbiased manner to enhance patient outcomes and support external stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team is an integral part of our...
-
Clinical Trials Coordinator
1 week geleden
Utrecht, Utrecht, Nederland HKU Voltijd{"h1": "Project Executive, Site Management", "p": "The Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under The University of Hong Kong LKS Faculty of Medicine (HKUMed).", "ul": ["Support project feasibility assessment", "Perform project logistics planning and coordination", "Coordinate research ethics...
-
Clinical Trials Coordinator
1 week geleden
Utrecht, Utrecht, Nederland HKU Voltijd{"h1": "Project Executive, Site Management", "p": "The Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under The University of Hong Kong LKS Faculty of Medicine (HKUMed).", "ul": ["Support project feasibility assessment", "Perform project logistics planning and coordination", "Coordinate research ethics...
-
Associate Director, Clinical Trial Associate Manager
2 weken geleden
Utrecht, Utrecht, Nederland Genmab VoltijdAbout the RoleWe are seeking a highly skilled and experienced Associate Director to join our Clinical Trial Associate Team as a Clinical Trial Associate Team Manager (CTA TM). This is a key leadership role within our Trial Strategy and Delivery department, responsible for managing a team of Clinical Trial Associates (CTAs) and supporting the delivery of...
-
Senior Clinical Trial Associate
1 week geleden
Utrecht, Utrecht, Nederland Genmab VoltijdAbout the RoleWe are seeking a highly skilled Senior Clinical Trial Associate to join our team at Genmab. As a key member of our Clinical Trials team, you will be responsible for overseeing the filing of documents to ensure inspection readiness at the trial level and supporting our GCTM/CTM with key administrative activities.Key ResponsibilitieseTMF...
-
Clinical Trial Disclosure Manager
2 weken geleden
Utrecht, Utrecht, Nederland Genmab VoltijdPosition OverviewAt Genmab, we prioritize the transparency of clinical research. We understand the importance of sharing clinical trial data in a timely and unbiased manner to benefit patients and other stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team operates within Development Operations, which encompasses essential functions for the...
-
Clinical Trial Disclosure Manager
2 weken geleden
Utrecht, Utrecht, Nederland Genmab VoltijdPosition OverviewAt Genmab, we prioritize the openness of clinical research. We understand the scientific and ethical importance of disseminating clinical trial data in a timely and unbiased manner to benefit patients and other stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team is part of Development Operations, which encompasses...
-
Clinical Trial Disclosure Manager
2 weken geleden
Utrecht, Utrecht, Nederland Genmab VoltijdPosition OverviewAt Genmab, we prioritize the transparency of clinical research. We understand the importance of sharing clinical trial data in a timely and unbiased manner to benefit patients and stakeholders alike. The Clinical Trial Disclosure & Transparency (CTD&T) team is an integral part of our Development Operations, which encompasses essential...
-
Project Manager, Clinical Trials
3 dagen geleden
Utrecht, Utrecht, Nederland HKU VoltijdProject Executive, Site ManagementThe Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under The University of Hong Kong LKS Faculty of Medicine (HKUMed). We are seeking a high-calibre talent to join our Site Management Unit (SMU) as a Project Executive, Site Management.Main Responsibilities:Support project...
-
Research Nurse
2 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdJob Title: Research Nurse - Clinical Trials CoordinatorJob Summary: We are seeking a highly motivated and experienced Research Nurse to join our team at the School of Public Health, HKU. The successful candidate will be responsible for coordinating clinical trials, managing stakeholder relationships, and providing excellent patient care.Key...
-
Clinical Trials Data Specialist
1 week geleden
Utrecht, Utrecht, Nederland HKU VoltijdJob Title: Data CoordinatorHKU-CTC is seeking a highly skilled Data Coordinator to join our team in the Clinical Trials Centre. As a Data Coordinator, you will play a critical role in managing and facilitating international-standard clinical trials on new drugs, medical devices, and medical technologies.Main Responsibilities:Develop and implement data...
Clinical Trial Monitor
3 maanden geleden
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 followup 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.
- 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.
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