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Clinical Research Project Manager

Title:                     Clinical Research Project Manager

Location:            Nashua, NH

 

Company

This is an exciting opportunity to join an early-stage medical device company conducting a large pivotal clinical program in the structural heart space. Conformal Medical is seeking a Clinical Research Project Manager to lead US IDE clinical trial execution including planning, implementation, and operations to ensure trial deliverables are met according to timelines, budget, quality standards, and GCP.

 

Essential Responsibilities and Duties

  • Oversee all clinical operational aspects of the IDE pivotal trial based on guidance from supervisor
  • Manage the internal and external vendors
  • Provide operational input on protocols and aspects of clinical trial management
  • Responsible for study start-up (IRB/EC submissions) and study operational activities including managing essential documents
  • The primary contact and resource for all study coordinators/vendors, internal clinical document management team for operational guidance and direction
  • Work collaboratively with internal team and provide mentorship to junior clinical staff
  • Provides monitoring oversight including providing input on monitoring plan, reviewing monitoring visit reports, and performing periodic oversight visits to sites and/or vendors to assess progress and compliance
  • Manage trial budget and maintain management reporting metrics
  • Ensures the trial master file and essential documents are maintained throughout the trial and performs inspection readiness checks throughout the lifecycle of the trial

 

Minimum Requirements

  • Bachelor’s degree required, in health or life sciences preferred
  • 3 to 5 years of clinical research experience at a Medical Device Manufacturer or CRO, at least 2 years direct clinical study management experience
  • Experience in clinical trial management and oversight of large PMA-track RCTs, and preparing IRB/EC submissions
  • Excellent organizational, interpersonal, and communication skills; ability to communicate effectively, both orally and in writing
  • Good working knowledge of GCP guidelines and other applicable regulatory guidelines required
  • Excellent communication and computer skills
  • Travel up to 60%

 

Preferred Qualifications

  • Experience working on PMA track IDE studies that comply with IDE regulations
  • Independent monitoring experience as a CRA managing investigator sites
  • Knowledge of Cardiovascular Physiology and structural heart anatomy is a strong preference

 
If interested, please contact info@conformalmedical.com