|
WHAT
IN
Sr Clinical Research Spec
Job
Medtronic
US
-
Santa Rosa,
California
Job Code - 68285
Position - Full Time - Regular
Job First Active on: Monday, October 26, 2009
APPLY TO THIS JOB (You will be applying directly to Medtronic for this position!)
JOB DESCRIPTION: Sr Clinical Research Spec
Incumbent has strategic and resource management responsibility for assigned clinical programs/studies to evaluate performance, safety and efficacy of major, new products and/or modifications to existing products. Accountable for resource prioritization, successful and timely completion of studies, coordination of activities with clinical affiliates in worldwide studies, in conformance with applicable federal regulatory requirements where appropriate. This work is accomplished with minimal supervision.
REQUIREMENTS - QUALIFICATIONS: Sr Clinical Research Spec
Additional Management Responsibilities
• Manage clinical study personnel focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies.
• Enlist support and specify tasks for various clinical and project team members to assure meeting study objectives on schedule.
• Supervise training of investigations, site staff, and Medtronic clinical staff.
• Oversee set-up and maintenance of accurate study status and implant procedure logs.
• Interface with representatives from key functional groups to drive clinical wide or cross-departmental initiatives.
• Ensure appropriate resources and priorities are maintained for various projects assigned to their area.
• Oversee clinical research staff with all aspects of their responsibilities.
• Supervise and review adverse event information.
• Compile, review, and conclude device complaints.
• Manage study closure activities.
Additional Management Requirements
• Strong knowledge of clinical research study design.
• Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003
• Good Clinical Practice(GCP)
• Experience managing cardiovascular medical device and/or pharmaceutical trials.
• Experience managing clinical trials from start to finish
Basic Qualifications
• Bachelors Degree in a scientific field of study.
• Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
• Minimum 6-9 years experience directly supporting clinical research or relevant experience in medical/scientific area.
• Masters degree will substitute for 1 year of experience. PhD or MD will substitute for 2 years of experience.
• Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.
• Computer skills (MS Office products, word processing, spreadsheets, etc.).
• High attention to detail and accuracy.
• Ability to manage multiple tasks.
• Good prioritization and organizational skills.
• Excellent problem solving skills
• Positive outlook.
• Flexible and dependable.
• Works effectively on cross-functional teams.
• Presents professional manner and appearance
Medtronics
Back To Results
Apply to this job!
View Company Jobs
Free Career Test
Your Resume on 75 Job Sites
|
The goal of CareerTopJobs is to help candidates find
jobs more easily, like the job listed on this page, "Sr Clinical Research Spec, in Santa Rosa, California - Medtronic". We hope CareerTopJobs will become your job source for finding open job positions in the
Biotechnology and
Pharmaceutical industry job market.
