Advanced Clinical
Advanced Clinical

60 Advanced Clinical Clinical Study Manager Jobs Hiring Near You

Clinical Study Manager The Clinical Study Manager is responsible for the end-to-end management and execution of clinical studies supporting medical device development. This role leads cross ...

Manager, Clinical Study Lead Build our future together: The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of ...

New

$150 - $200/hr

Timelines, Planning and Execution Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines

Study Manager I

Phoenix, AZ · On-site

$100 - $125/hr

A Study Manager is responsible to ensure that quality research is conducted at assigned ... Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator ...

Manage and maintain team SharePoint sites and/or shared drives as needed. * Communicate with ... advanced degree in a related field with 1-2 years of relevant experience preferred. * Strong ...

Showing results 41-60

Senior Manager, Clinical Studies

Inspire Medical Systems Inc.

Minneapolis, MN • On-site

Full-time

Re-posted 4 days ago


Job description

POSITION SUMMARY 

This position is for overseeing clinical activities related to one or more clinical studies and performing/managing the daily in-house operations associated with the studies. The Clinical Study Manager must be able to work independently on multiple complex clinical studies using critical thinking skills. This position may be part of a small, cross functional team or may have direct reports. 

 

MAIN DUTIES/RESPONSIBILITIES 

  • Responsible for managing clinical studies in accordance with internal standard operating procedures and applicable regulations and guidelines 
  • Collaborate with internal and external clinical team members, consultants and/or CROs to draft clinical study protocols and other clinical study documentation 
  • Oversee clinical site selection and activation 
  • Manage study safety by tracking and reporting adverse events as required by regulatory bodies, reviewing adverse event trends, and overseeing safety committees including Clinical Events Committees and Data Safety Monitoring Boards 
  • Oversee monitoring activities related to assigned clinical studies including review and approval of monitoring plan and monitoring reports, managing monitoring schedule and ensuring corrective action related to monitoring findings 
  • Develop training plans for study training and review/approve training documentation 
  • Prepare study-related reports including annual, interim and final study reports 
  • Organize and lead study-related conference calls and Investigator meetings as needed through the study 
  • Oversee investigational device allocation, distribution and reconciliation 
  • Collaborate with data management team and/or CRO to ensure appropriate data capture, query management and to identify data analysis needs 
  • Use critical thinking skills to review and analyze scientific journal articles 
  • Assist with generation and/or review of study-related abstracts, posters, presentations, manuscripts as needed 

QUALITY SYSTEM RESPONSIBILITIES 

  • Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed. 
  • Complete training requirements and competency confirmations as required for this position within the required timeline. 
  • Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement. 
  • Ensure all direct reports maintain training records that comply with applicable quality system requirements. (if applicable) 

 

QUALIFICATIONS 

Educational Requirements: 

  • Required: Bachelor's Degree required 
  • Preferred: Science Degree preferred (Biology, Chemistry, etc.) 

 

Required Experience: 

  • Previous clinical research experience (minimum 5 years) required 
  • Previous clinical study management experience preferred 
  • International clinical experience preferred 
  • Previous collaboration with physician investigators 
  • Strong knowledge of clinical research study design and study monitoring functions 
  • Understanding of GCP and 21 CFR 812 
  • Experience working with Institutional Review Boards and/or Ethics Committees 
  • Strong technical writing skills 

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