Clinical Site Manager

What you will be doing:

  • Develops key site relationships with the site personnel and serves as the point of contact for operational and process related issues and inquiries for assigned trial(s).
  • Responsible for managing site activities to ensure delivery of site targets.
  • Provides direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site to ensure delivery of targets and quality.
  • Proactively manage site activation and maintenance progress, expectations and deliverables as applicable.
  • Collaborate with Clinical Affairs Clinical Project Manager(s) and Clinical Research Associate(s).
  • Verify the accuracy and timeliness of trial information in all trial databases and tracking systems.
  • Actively monitor subject screening, enrollment and recruitment efforts.
  • Review and provide input to core study documents, as applicable.
  • Distribute start-up and maintenance related documents to local start-up staff and oversee the customization to local requirements.
  • Track ethics and regulatory bodies submissions, approval and response status ensuring required timelines are met.
  • Assist implementation of Site Initiation Visits (SIVs) to monitor and motivate sites and proactively address key issues.
  • Train site personnel, including investigators, study coordinators and other key personnel in screening, recruitment and study procedures.

 

What you have:

  • Bachelor’s degree required in medical/healthcare-related science field.
  • Minimum two years of clinical trial experience (preferably in medical device industry).
  • Experience with global regulatory processes are welcomed. Experience with various international clinical trials regulations also desirable.
  • Demonstrates current working knowledge of operational and regulatory processes involved with clinical trials.
  • Demonstrates skills to manage electronic systems such as EDC, Excel, CTMS, and eTMF, RMF, Sharepoint and others as applicable.
  • Demonstrates technical competence and experience in implementation, tracking and completion of global clinical trials to commercialization with highest standards of quality and GCP and the ability to deliver trials on time and within budget.
  • Knowledge tracking of clinical trials and effective management of assigned internal and external resources to achieve successful results.
  • Ability to collaborate with diverse, global cross-functional matrix teams.

 

Advantages:

  • In-depth knowledge of clinical trial processes and regulations
  • Understanding of principles of regulations.
  • Demonstrates current working knowledge of operational and regulatory processes involved with clinical trials.
  • Being introduced by an Insightec employee

 

Successful candidate(s) will be required to comply with Insightec’s Vaccination Policy. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender/gender identity, age, disability, marital status, sexual orientation, national origin, veteran status, and any other legally protected status entitled to protection under federal, state, or local anti-discrimination laws.

 

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