Clinical Project Manager Spinal Kinetics
THIS JOB HAS EXPIRED Job description
This position resides at the corporate headquarters in Sunnyvale, CA. Applicants MUST be local to the San Francisco Bay Area, as relocation is not an option.
PURPOSE OF JOB:
In conjunction with the Director of Clinical Research, manage the company?s clinical research activities, in accordance with Good Clinical Practices. Develop and implement departmental policies and procedures. Work with the Research & Development Department in determining clinical feasibility of new products.
MAJOR DUTIES AND RESPONSIBILITIES:
Participate in the development and implementation of effective clinical study protocols for company products.
Participate in the preparation of technical and scientific publications.
Establish and implement clinical research procedures and policies.
Responsible for establishment and maintenance of study Central Files.
Monitor ongoing compliance to study protocols, FDA regulations, and IRB requirements.
Participate in the qualification, initiation and interim monitoring of clinical sites as needed.
Work with Regulatory Affairs staff in providing accurate and timely reports such as annual reports, safety reports and study summaries for FDA submissions or other regulatory documents. .
Manage relationships with external Clinical Research Organizations, Data Management companies, monitors and consultants.
Oversee the development and maintenance of computerized data collection system.
Oversee and report on the proper collection of data.
Manage ongoing analysis and synthesis of collected data.
Prepare accurate and timely reports to senior management.
Complete projects and tasks in a manner consistent with corporate objectives.
Attend relevant scientific and medical meetings, and make presentations on company studies.
Support company goals and objectives, policies and procedures, Good Clinical Practices, MDD, FDA, ISO and QSR regulations.
Desired Skills and Experience
BS in Life Sciences (preferred) or other technical discipline. Minimum five years clinical research experience including the management of multi-center clinical trials, preferably in the field of spine arthroplasty. Excellent written and verbal communication skills. Knowledge of FDA regulatory requirements. Computer literacy is required as are database management skills.
The dexterity to use a computer keyboard and various forms of office equipment. May sit for extended periods of time. The ability to read, write and follow complex directions. The ability to communicate effectively, both verbally and in writing with co-workers, management, doctors, distributors, and regulatory agencies. May require travel, approximately 20 to 30% of time.
About this company
Founded in 2003, Spinal Kinetics is a privately-held medical device company focused on partnering with spine surgeons to develop innovative and practical motion preservation systems for treating degenerative diseases of the spine.
The M6 artificial disc is the first of these non-fusion motion preservation products intended to replicate the anatomic and biomechanical attributes of a natural intervertebral disc. The M6 is the only artificial disc that mimics a natural disc?s design by incorporating an artificial nucleus and annulus into both its cervical and lumbar platforms.
||San Francisco, CA |
THIS JOB HAS EXPIRED