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Global Trial Specialist
View: 183
Update day: 03-04-2024
Location: Boudry Neuchâtel NE
Category: Other
Industry: Pharmaceutical Manufacturing
Position: Associate
Job type: Full-time
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Job content
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.The Global Trial Specialist Contributes to the operational execution of clinical studies and supports complex global trials as needed.
Objective
- Provides operational input on development, management and maintenance of study deliverables (i.e. timelines, study plans, documents, etc.) through collaboration with internal and external stakeholders.
- Drives process / system enhancements related to GTS responsibilities / deliverables and manage / comply with various quality or compliance systems
- Manages country planning, protocol level attributes and milestones/drivers in CTMS.
- Manages the development and/or collection of study level documentation, support GTM in ensuring eTMF accuracy and completion for all studies.
- Manages the global setup of study level non-clinical supplies.
- Understands study level tools and plans.
- Provides support to the GTM along with the appropriate teams for response to country/regulatory and IRB/IEC.
- Provides operational input and participates in operational processes in support of the startup maintenance and close out of studies.
- Assist the GTM in driving study execution.
- Learns, observes and performs core GTS tasks and escalates appropriately.
- Facilitates vendor creation and payment processing in conjunction with the appropriate stakeholders.
- Raises possible issues for potential escalation to the appropriate colleagues.
- Follows instructions, determines level of understanding and seeks clarification when needed.
- Seeks guidance to navigate undefined tasks, challenges, and study tools/resources
- Develops, updates, and submits Transfer of Obligations to Regulatory Authorities.
- Manages global vendor site lists and resolve issues related to global site lists.
- Manages study mail-groups/distributions and SharePoint/Study Directory updates.
- Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.
- Identifies issues and risks, develops mitigations, and escalates appropriately.
- Participates in filing activities and any associated audits as applicable
Experience Requirements
- Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems is a plus.
- Experience in Clinical Research or related work experience.
- Global experience is a plus.
- Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments is preferred.
- Knowledge of ICH/GCP and regulatory guidelines/directives.
- Basic understanding of project management desired.
- Begin to network and foster relationships with key stakeholders across the study team.
- Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
- Displays a willingness to challenge the status quo and take risks.
- Effective oral and written communication skills, ability to influence crossfunctionally, demonstration of leadership capabilities.
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.
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Deadline: 18-05-2024
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