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Clinical Research Manager

Title:                             Clinical Research Manager

Benefits:                      Healthcare, Dental, 401(k), Stock Options

Reporting To:             VP of Clinical

Location:                     Nashua, NH

 

Company

This is an exciting opportunity to join an early stage medical device company preparing to initiate a large RCT in the structural heart space. Conformal Medical is seeking a Clinical Research Manager to lead clinical trial execution including planning, implementation and monitoring to ensure trial deliverables are met according to timelines, budget, quality standards, and GCP.

 

Essential Responsibilities and Duties

  • Provides input to the clinical development plan, protocols and operational aspects of clinical trial protocols
  • Responsible for study start-up and study conduct activities including managing essential documents
  • The primary contact and resource for research sites and study coordinators for day-to-day study operations
  • Provides monitoring oversight including authoring of monitoring plan, reviewing monitoring visit reports and perform periodic oversight visits to sites and/or vendors to assess progress and compliance
  • Identifies and/or anticipates operational risks and mitigation plans within assigned clinical trials and escalates issues and recommends contingency plans as necessary
  • Ensures the trial master file and essential documents are maintained throughout the trial and performs inspection readiness checks throughout the lifecycle of the trial
  • Managing and communicate the status of study progress and activities

 

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 RCTs, and developing clinical trial protocols 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 50%

 

Preferred Qualifications

  • Experience working on 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