IMPERATIVE CARE Clinical Trial Manager Salary in the United States

SUMMARY: Manages all aspects of clinical trial, including study initiation, monitoring, site management, CRO management and facilitate clinical programs. This job contributes to and supports the company's research and development efforts to create high value medical devices to address unmet clinical needs.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

• Manage clinical trials from beginning to end, including site qualification, initiation, monitoring and close-out.
• Contribute to the development and initiation of clinical study concepts with internal and external customers
• Develop/edit protocols, case report forms, database specifications, and statistical plans
• Manage study sites to ensure enrolment is on track
• Manage CROs to ensure the study is conducted in compliance
• Provide strategy to improve enrolment and study conduct compliance.
• Assist site personnel with data queries as needed to ensure clarity and accuracy of data
• Ensure site adherence to the study protocol, relevant SOPs, GCP/ICH guidelines, HIPAA, trial registration, and all other applicable regulatory guidelines
• Coordinate internal data analysis and required outside statistical analysis to meet both protocol-identified and additional investigator statistical analysis objectives
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA and applicable regulatory regulations.
• Support the Quality System and Quality Policy.  Be aware of Quality System procedures and requirements, including regulatory requirements and training requirements for position activities. Inform responsible personnel of concerns involving product quality
• Perform job functions in a safe and effective manner
• Other duties as assigned

EDUCATION/EXPERIENCE:                                                                                                                                  

• Bachelor’s degree in related field and 5+ years clinical research management experience, preferably in medical device industry.
• Experience in IDE studies and neurovascular therapeutic area is strongly desired
• Extensive knowledge of FDA requirements, hospital, and health care environments
• Strong knowledge of GCPs
• 1-2 years experience in direct management of clinical teams preferred
• Excellent written and verbal communication skills required
• Experience interacting with physicians, clinicians, and patients
• Must be willing to travel 20 - 30%.  
• Ability to be very flexible, adaptable, and to work under pressure.
• Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while staying flexible to shift tasks frequently
• Excellent interpersonal and negotiating skills; ability to adapt to changing work priorities; and ability to maintain good working relationships while dealing appropriately with sensitive and confidential matters and with a wide variety of personal and telephone contacts
• Demonstrated record of success