Clinical Trial Manager Job at Genabio Diagnostics, Bedford, MA

QllTU3FXcExCVENNUlA0aURoYlh6MFA2OVE9PQ==
  • 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

Diamonds International

Data Entry Specialist Job at Diamonds International

Diamonds International is looking for a Data Entry Specialist! This is a great opportunity for someone to attain data processing in the luxury jewelry industry, while utilizing their data entry and clerical skills! Clerical duties include being responsible for accuracy...

It's Your Night Entertainment

Customer Experience & Event Operations Coordinator Job at It's Your Night Entertainment

 ...Customer Experience & Event Operations Coordinator Location: DFW Metroplex (in-office in Roanoke, with some work-from-home flexibility) Schedule: Full-time, MondayFriday (occasional evenings/weekends, but rare) Who We Are Its Your Night (IYN) is a wedding... 

PNW Intermodal

Operations Dispatcher Job at PNW Intermodal

 ...About the Role - PNW Intermodal is hiring an Operations Dispatcher to work at our Kent terminal. The ideal candidate will have 2...  ...identifying areas for improvement and providing feedback and training as necessary. Will be required to collaborate with the Terminal... 

Bare Home

Data Scientist Job at Bare Home

 ...excellence has earned us a reputation as an industry leader in sustainable and ethical textile sourcing. Position Overview: As a Data Engineer, you'll serve as the technical backbone for our $100M+ bedding and mattress business, building and maintaining the data... 

Emerson and Friends

Inside Sales Representative Job at Emerson and Friends

 ...InsideSales Representative Emerson and Friends Clearwater, FL ABOUT EMERSON AND...  ...dedicated to producing imaginative and high-quality products. What began as a family...  ...BENEFITS ~ Competitive salary and commission structure ~ Medical Insurance ~ Dental...