Clinical Scientist, Cell Therapy - Boudry, Schweiz - Bristol Myers Squibb
Beschreibung
Working Environment
Exciting. Significant. Life-altering. Those are not words you frequently hear to describe a job. However, being part of Bristol Myers Squibb is far from ordinary. Each day, fascinating work takes place across all departments that have a real impact on patients' lives and the professional journey of those involved.
From optimizing production processes to pioneering advancements in cell therapy, our work is truly transformative.
Join a diverse, high-achieving team and seize opportunities for personal and career growth that are on a different scale.
Take your career to new heights.Functional Area Overview
The Clinical Scientist role offers essential scientific expertise for the planning and implementation of clinical studies and programs.
Job Summary
- Responsible for designing and executing assigned clinical trial activities, collaborating closely with the clinical team members on the project
- Potential role as the lead Clinical Trial for one or more trials
- Direct or support trial-level tasks for one or more trials under appropriate supervision
- Lead study team meetings alongside GDO protocol manager and engage with cross-functional study team members
Role Responsibilities
- Collaborate with and engage external partners (e.g., Key Opinion Leaders)
- Implement best practices as instructed
- Provide regular updates to management as needed
- Develop Protocol and Informed Consent Form (ICF) documents, present for review at governance committees and development team meetings
- Perform literature reviews
- Organize clinical document submission to Trial Master File (TMF)
- Create training materials for sites and Clinical Research Associates (CRAs) and present at Site Initiation Visits (SIVs) and Investigator meetings
- Review clinical narratives
- Monitor clinical data trends
- Collaboratively develop Data Review Plan with Data Management
- Ensure CRF design supports data collection in line with the protocol in collaboration with Data Management/Programming
- Contribute clinical content to Clinical Study Reports (CSRs) and regulatory documents
Educational Requirements
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or related scientific field preferred). Suitable for newcomers to the pharmaceutical industry
Experience Criteria
- Fundamental knowledge of GCP/ICH, drug development processes, study design, statistics, and clinical operations
- Ability to comprehend assigned protocol(s) and their demands
- Fundamental skills to facilitate program-specific data review and trend identification
- Intermediate proficiency in medical writing and terminology
- Basic planning/project management abilities
Key Skills
- Detail-oriented with a dedication to quality
- Foundational understanding of disease area, compounds, and the current clinical landscape
- Knowledge of data monitoring committees, dose review teams, and independent response adjudication committees
- Intermediate critical thinking and problemsolving skills
- Adaptable and flexible, capable of facing daily challenges with confidence and professionalism
- Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools
Travel Expectations
Travel, both domestic and international, may be necessary.
Fascinating Work, Career-changing Opportunities
On-site Requirement
Being physically present at the BMS worksite or in the field is a vital aspect of this role, crucial for collaboration, innovation, productivity, employee well-being, and fostering the Company culture.
COVID-19 Consideration
BMS evaluates applicants with prior arrest and conviction records for employment, adhering to relevant laws in respective areas.
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