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SR CLINICAL SCIENTIST
| Details |
Country: USA
Location: NJ Lawrenceville
Total applied: 27
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SR CLINICAL SCIENTIST
Job Responsibilities:
Demonstrates thorough knowledge of drug development and regulatory processes.
Understand clinical research process. Ability to manage project timelines.
Responsible for conducting studies with minimal supervision. Demonstrates
understanding of pharmacokinetic and pharmacodynamic principles. An
understanding of human physiology and pharmacology principles. Competence in
BMS SOPs, project standards, and global requirements. May represent Clinical
Discovery in SOP developmentprocess. Knowledge of good clinical practices and
ICH guidelines and application. Compiles IND updates and contributes to
appropriate sections of InvestigatorBrochures, IND NDA MAA Submissions.
Prepares protocols, CSRs and other projectrelated documents. Provides training
mentoring of entry level clinical scientists new to the department through
mentoring and formal presentations. Monitors Clinical Discovery studies and
updates the clinical team on an ongoing basis identi fies issues and works with
members of the team to resolve issues. May coordinate activities for multiple
protocols within a given program. Demonstrates good oral written communication
skills. Leads interdisciplinary program teams. Contributes to discussions
regarding scientific integrity of protocols and reports. Ability to work
effectively in a team environment. Effectively handles multiple tasks
simultaneously. Demonstrates competence in required computer applications and
is able to function within an environment that relies heavily on technology for
information and communication. May assist with development of clinical plan.
Participate and or leads department initiatives. Participates in PRI and
company wide initiatives. Demonstrates flexibility and openness to change.
Function as role model on department initiatives. Understands literature,
extracts appropriate information and applies knowledge to protocols, clinical
study reports, and other related documents. Ability to determine limitations
and use situational analysis to
Job Requirements/Education:
Extensive experience in clinical research in the pharmaceutical or medical
industry. Extensive experience in writing and conducting Phase 1 clinical
trials andor equivalent experience. Experience in writing scientific and or
clinical documents. Experience in leading teams. Extensive experience
delivering projects with exemplary accuracy and attention to detail.
Demonstrated ability to work independently and with self motivation. Effective
scientific presentation skills. Negotiation skills. Experience with managing
budgets. Experience in providing mentoring and training. Knowledge equivalent
to that attained with a Bachelors degreeRN and 5 to 7 years related experience,
Masters degree and 3 to 5 years relatedexperience, or PharmD PhD degree with 2
to 3 years clinically related experience. Knowledge and understanding of Good
Clinical Practices GCP and International Conference on Harmonization ICH
Guidelines. Knowledge of clinical pharmacology principles and human physiology.
Working knowledge and understanding of software applications including Windows,
word processing, spreadsheet development including graphing function. Knowledge
of clinical research including Phase I to IV processes, procedures and
timelines. Understanding of data management and statistical analysis process.
Understanding of the pharmaceutical industry. Good understanding of project
planning and management.
Salary will be commensurate with experience.
Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D
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