 |
|
Clinical Project manager
Education and/or Special Training:
• MD/PHD with a minimum of 3 years of clinical trials experience and/or orthopedic or neurology of the spine practice experience or Bachelors in Nursing with minimum7 years clinical trials experience (orthopedic therapeutic area experience a plus) or Bachelors in Biological Sciences or related discipline with minimum of 7 years clinical trials experience including orthopedic devices/indications
Job Description:
The Clinical Project Manager will collect, evaluate and report safety data for multiple prospective IDE clinical trials for a medical device company. Accomplish this by working with Clinical team on data collection, planning and coordinating independent reviews, and by preparing and reviewing reports of case and aggregate safety data for annual study reports and PMA submission.
Specific duties include:
• Responsible for adverse event tracking, review, classification and reporting, including specification and/or enhancement of data flow processes.
• Plan and oversee CRO development and maintenance of Data Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC)
• Manage sponsor interaction with DSMBs for multiple clinical trials
• Manage sponsor interaction with CECs for multiple clinical trials
• Track and troubleshoot efficiency of safety and supporting data flow from sites to data management and independent reviewers
• Support PER (complaint) investigations involving patients treated with devices that are, or have been, under a clinical IDE investigation by company.
• Collaborate with study managers, data management, regulatory affairs and monitoring group to support study training, data collection, clean-up and reporting with respect to safety surveillance and adverse event reports
• Develop and implement standard operating procedures as necessary
• Create and update safety narratives for annual and PMA reports
Compensation depending on experience
contact
Jamie@pharmasearchpartners.com
|
| Additional Information |
Salary: $110000 to $140000
Position Type:
Employee
Ref Code: 003jr |
|
|
|
|
