Sr. Clinical Study Manager

8 - 10 years experience  • 

Salary depends on experience
Posted on 03/20/18
8 - 10 years experience
Salary depends on experience
Posted on 03/20/18

SUMMARY

As a Senior Clinical Study Manager you will be responsible for providing project management leadership and project team representation, initiation, monitoring, completion and reporting of clinical studies.  These studies will be primarily pre-market clinical investigations.  

 

RESPONSIBILITIES

  • Execute clinical trials in compliance with FDA regulations, ICH guidelines, ISO and GCP requirements and in alignment with business goals and objectives
  • Establish, manage and achieve the milestones of clinical studies, select CRO, Core Laboratory, Advisory and Adjudication Board, manage and communicate with investigators, manage monitoring and budget in an accurate and proactive manner
  • Develop clinical study documents such as protocols, clinical trial plans, case report forms, worksheets, informed consent, etc.
  • Produce professional correspondence, clinical reports, presentations and training materials
  • Acquire expertise in devices and therapies, patient population and alternative modalities via independent reading and training
  • Drive implementation of LEAN initiatives
  • Model positive team interaction and cooperation in a matrix environment
  • Lead and influence business partners at all levels of the organization
  • Promote and effectively manage change, adapting to changing business/project priorities appropriately
  • Travel approximately 10-20% (as project needs require)

 

REQUIREMENTS

  • Bachelor’s Degree in a scientific area of study
  • 8+ years experience in clinical research
  • 2+ years project management experience in a clinical research setting
  • Experience in clinical trial monitoring
  • Experience with international clinical studies and CRO management
  • Understanding and adherence to FDA regulations, ICH guidelines, ISO and GCP requirements as well as department Standard Operating Procedures
  • Strong interpersonal skills, ability to constructively interact with a range of personalities and positions both inside and outside the organization
  • Demonstrated ability to identify study issues and implement solutions, including identifying and involving the appropriate decision makers
  • Strong organizational skills, flexibility and ability to change priorities rapidly 
  • Technical/medical writing capability 
  • Computer proficiency in Microsoft Office Suite 
  • Effective verbal and written communication with high attention to detail and accuracy
  • Medical device experience (Class III)

 

PREFERENCES

  • Advanced degree 
  • Medical and technical aptitude
  • PMA experience with IDE studies
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