Clinical Trial Manager Job at Genabio Diagnostics, Bedford, MA

U3dZQ3lHVkQvcE1VMWZacXZGZDRicVo2
  • Genabio Diagnostics
  • Bedford, MA

Job Description

Job Responsibilities :

  • Manage assigned clinical studies within a designated budget and timeline.
  • Conduct CRO, Vendor and site assessment and selection; negotiating budget and contracts.
  • Conduct site qualification, initiation, interim monitoring and close-out visits. Collecting and reviewing trial master documentation. Document results of visits in monitoring reports for review and finalization.
  • Facilitate IRB submissions and renewals when needed.
  • Oversee clinical sites, central lab, and other third parties to ensure issues are resolved timely. Motivating investigational sites to close queries and action items.
  • Develop or review clinical project plans and clinical trial documentation.
  • Collaborate with Regulatory to prepare FDA pre-submission and submission packages.
  • Oversee the development of a clinical study database by third party, review and summarize clinical data, perform data analysis and reports.
  • Oversee all study team members training to ensure accurate execution of clinical protocols.

Qualifications:

  • Bachelor’s degree (or higher) in science or health-related discipline
  • Minimum 3 years of clinical research experience for medical device and IVD products, specialty in respiratory diseases or STD is preferred
  • Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
  • Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
  • Ability and willingness to travel ~10-15% of the time

Job Tags

Interim role,

Similar Jobs

Bear Peak Capital

Apartment Maintenance Technician Job at Bear Peak Capital

 ...As a Maintenance Technician, youll be responsible for completing work orders and assisting with the day-to-day upkeep of our apartment...  ...and carpentry as needed, and taking care of routine upkeep like lighting, locks, painting, and general property repairs. Youll also... 

Grimco, Inc.

Local Delivery Driver Job at Grimco, Inc.

 ...company where the people are the purpose? At Grimco, our Local Delivery Drivers aren't just part of a team they're a vital part of our...  ...~ A Smart Phone ~ Ability to lift and carry packages weighing up to 60 lbs. Benefits ~ Full medical, dental, and vision benefits... 

BHE GT&S

Telecom Technician 1/Telecom Technician 2/Telecom Technician 3 Job at BHE GT&S

 ...monitoring, operations, installation, and/or maintenance for local off-site and/or remote locations. Instructs, directs, and checks the work of telecommunications technician personnel. Works with an individual business unit on multi-project assignments. Monitors... 

Right Restoration Partners

Mitigation Sales Specialist Job at Right Restoration Partners

 ...Mitigation Sales Specialist Location: 8421 Hegerman St, Philadelphia, PA 19136 As a Mitigation Sales Specialist, you are often the first face our customers see during one of their most stressful moments dealing with water damage in their home or business. Your primary... 

Diane's Travel Business

Personal Travel Assistant-Entry Level (Virtual) Job at Diane's Travel Business

We are seeking a highly organized and customer-focused Personal Travel Assistant to join our remote team. In this role, you will assist clients with booking travel arrangements, managing itineraries, and providing tailored recommendations to enhance their travel experience...