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WHAT
IN
Sr. Clinical Research Associate Study Manager-Pharmaceutical
Job
Bauch & Lomb
US
-
Rochester,
New York
Job Code - 5354BR
Position - Full-Time
Job First Active on: Thursday, October 29, 2009
APPLY TO THIS JOB (You will be applying directly to Bauch & Lomb for this position!)
JOB DESCRIPTION: Sr. Clinical Research Assoc. Study Manager-Pharmaceutical
Job Duties:
- Assumes project management responsibilities for assigned clinical studies; participates in project planning, budget negotiations and expense analysis
- Conduct and manage high profile clinical studies/trials which includes working closely with internal study team members/clinical scientists
- Although this is an in-house position, you will still interact with investigative site personnel
- Oversee execution of protocol
- Contributes to the clinical protocol study design, development of Case Report Forms (CRFs), quality assurance, data management and reporting activities
- Has involvement with Clinical Research, Clinical Operations and Project Mgmt of drug development activities
- Identifies and evaluates issues related to the project and implements resolutions
- Assumes in-house monitoring, assigns field monitors to projects as needed and required by GCP; performs on-site monitoring as needed by GCP
- Participates in Investigator selection, recruitment and training and provides final recommendations
- Plans and creates presentations of clinical research study information
- Provides input on departmental decisions related to process and procedures
- Minimal to no overnight travel (company uses CROs to perform field monitoring)
REQUIREMENTS - QUALIFICATIONS: Sr. Clinical Research Assoc. Study Manager-Pharmaceutical
- Education: BA/BS(scientific field preferred). Clinical Research Associate certification a plus
- 2 years of experience managing clinical trials, clinical trials resources and utilizing project management skills
- 4 years of experience as a pharmaceutical study monitor with both in-house and field monitoring background preferred
- Knowledge and understanding of current regulations related to Phase I - IV clinical research
- Strong working knowledge of FDA, ICH and GCP guidelines. Knowledge of project management tools and practices
- Ability to understand and review detailed clinical reports
- Excellent communication and organizational skills.
- Specialized Training: Courses in Clinical Research Monitoring and Clinical Project Management; Comprehensive knowledge of Microsoft Word, Excel and PowerPoint.
Bausch & Lomb
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