Conformal Medical is seeking a Clinical Study Manager to support US IDE clinical trial execution including planning, implementation, and operations to ensure trial deliverables are met according to timelines, budget, quality standards, and GCP. This role will report directly into the Vice President of Clinical Affairs. This role requires previous experience managing project timelines for a medical device clinical trial.  While Conformal Medical is based in Nashua, NH, we are open to candidates throughout the continental US.  Candidates must be located near a major US airport hub. 

 

Our ideal candidate is a self-starter with a positive attitude who can adapt quickly, who will thrive in a fast-paced environment with minimal supervision. When priorities shift, this person can lead and direct with ease. This person will be responsible for communicating and escalating issues up to senior management, thus strong communication/presentation skills are preferred.

 

Essential Responsibilities and Duties

  • Manages the clinical trial timeline, resources and vendors along with the Senior Manager, Clinical Operations
  • Performs site visits as needed
  • Conducts monitoring visits: qualification, initiation, interim and close-out. Develops and reviews monitoring visit reports.
  • Contributes to the development of essential study documents: protocol, informed consent, annual progress reports, etc.
  • Develops study resources such as manual of operations, source worksheets, patient recruitment materials, etc.
  • Organizes and prepares presentations for investigator meetings
  • Supports maintenance and integrity of the trial master file
  • Supports EDC development (e.g. user acceptance testing) and maintenance (i.e. resolving queries)
  • Supports shipping, return and management of investigational product
  • Supports clinical vendor qualification, management and evaluation
  • Ensures the trial master file and essential documents are maintained throughout the trial and performs inspection readiness checks throughout the lifecycle of the trial
  • Contributes to the development of standard operating procedures (SOPs)
  • Mentors and train junior staff members

 

Minimum Requirements

  • Bachelor’s degree required, in health or life sciences preferred
  • 5+ years of being a CRA at a Medical Device Manufacturer or CRO
  • 3+ years of monitoring experience
  • US & OUS clinical trial project management experience, preferably for Medical Devices
  • Proven ability to work independently with minimal supervision
  • Strong knowledge of US & EU GCP regulations and other applicable regulatory guidelines (ICH E6(R3), ISO 14155)
  • Strong knowledge of EDC systems
  • Strong computer skills in Microsoft Office
  • Excellent problem solving, organizational, interpersonal, and communication skills
  • Available to travel up to 30-45%

 

Preferred Qualifications

  • Previous experience managing PMA track IDE studies that comply with IDE regulations
  • Knowledge of Cardiovascular Physiology and structural heart anatomy
  • Previous experience with regulatory &/or notified body