Clinical Trial Manager Job at Genabio Diagnostics, Bedford, MA

N3lvSSsvZWp3QXdmbjFqazRTWG9RWi9ZcVE9PQ==
  • 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

Galileo Search, LLC

Clinical Director of Oncology Services | RN | Health System | Mountain West Region Job at Galileo Search, LLC

 ...Clinical Director of Oncology Services | RN | Health System | Mountain West Region Competitive Compensation | Superb Benefits Program | Relocation...  ...adolescent, adult, and geriatric populations Oversees outpatient oncology operations with cross-functional inpatient... 

Ledgent Technology

Talent Acquisition Specialist Job at Ledgent Technology

Temp Position - Open ended Pay: Up to $30 an hour, W2 Location: 100% on site in TX-Carrollton 75010 Overview: The Talent Acquisition Coordinator supports the department management and staff with recruitment processes, ensuring a seamless candidate experience...

Radiant Digital

Business Analyst Job at Radiant Digital

 ...Role Description: Conducts project initiation activities to identify current and future state requirements. Works with business and Information Systems staff to determine needs and produce Requirements Definition document that completely and clearly defines the... 

Integrity Staffing Solutions

Plant Operations Manager Job at Integrity Staffing Solutions

We are seeking a dynamic and experienced Plant Manager to lead our client's printing operation. This role is responsible for overseeing all aspects of production, packing, maintenance, safety, and quality within the facility. The ideal candidate will have experience...

Search Services

Senior Data Scientist Job at Search Services

ABOUT OUR CLIENT Our Client is a leading private equity firm with a portfolio of upstream gas production companies. By combining petroleum engineering expertise with advanced data analytics, artificial intelligence (AI), and machine learning (ML), Our Client is driving...