Rotate Device

Job Openings

Clinical Study Manager (Hybrid)

Role
Clinical Trial Management
Location

Irvine, CA

USA
Job Description

The Clinical Study Manager independently manages and monitors clinical study sites and/or CROs contracted to manage clinical studies sponsored by HSOU. Functioning as Lead on select projects in a Lead role, this position will be responsible to provide directions and training for other CRAs assigned to those projects. In addition, he/she is responsible for the oversight of all operational aspects related to the planning and management of clinical studies and site performance, to include but not limited to; study timelines, protocol compliance, data integrity and subject safety.

 

The Clinical Study Manger will be responsible for ensuring all personnel associated with the conduct and management of a clinical study have undergone the necessary study training and operate in compliance to the study protocol, GCP and respective Federal Regulations.

 

Key Duties and Responsibilities

  • Work closely with the CTM Team to develop and implement study enrollment and management strategies
  • Develop and maintain all study documentation, monitoring tools and plans
  • Day-to-day management of CRO
  • Day-to-day management of the study and clinical sites to ensure compliance, data quality and adherence to timeline incl. site quality activities
  • Organize Investigator Meetings/Conferences
  • Resolve study related issues (e.g., enrolment, protocol compliance, AEs/SAEs/DDs)
  • Manage relationship with investigators and site personnel, support teams and external consultants
  • Provide status updates to CTM Team and lead regular team meetings
  • Support the management and development of CRAs

 

NOTE: Key Duties & Responsibilities may not be limited to those listed within this section. Ordering of Key Duties & Responsibilities does not necessarily reflect importance of item.

 

Experience

  • At least 5 years of experience in clinical study management in medical device industry, preferably in ophthalmology
  • Familiar with ISO14155 (GCP) and 21 CFR 812 (Investigational Device Exemption (IDE)

 

Education

  • Professional education or a bachelor’s degree in a medical or scientific field, preferably optics

 

Functional Competency

  • Excellent interpersonal and written communication skills; pragmatic in problem solving; compliance mindset; systematic and disciplined
  • Proficient at database systems, and Microsoft Office
  • Demonstrate ability to lead projects and train, mentor and lead supporting team members; and understanding of medical/therapeutic area knowledge and medical terminology

 

Core leadership Competency

  • Strong organizational, interpersonal, written / verbal / influencing skills, with a strong attention to detail
  • Contribute to the overall morale of a team
  • Emotional intelligence, relationship building and conflict management
  • Decision making and task delegation
  • Self-reflection and personal accountability

 

Travel Requirements

  • Up to 40%

 

Work Conditions

  • Main work location is in the Irvine office
  • Standard office environment in the Irvine office

 

By submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes. For more information about the processing of your personal data, please refer to our Privacy Policy, which can be found here.

 

We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding.

Apply Now or E-Mail your resume to hso-ghq-hr@hoya.com; subject “Application for 'Job Title'”. Thank you!