Rotate Device

Job Openings

Clinical Study Manager (Hybrid)

Clinical Trial Management

Irvine, CA

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.



  • 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)



  • 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


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

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