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Clinical Research Project Manager, Nashua, NH

Clinical Research Project Manager, Nashua, NH

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


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