Clinical Trial Manager Job at Genabio Diagnostics, Bedford, MA

bzJKa3FQRWREOTJhclVLTWwxNWdaaFpXakE9PQ==
  • 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

Randstad USA

Merchandise Data Analyst Job at Randstad USA

 ...Join our iconic and world-renowned brand, as part of our Retail division. You will play a...  ...merchandise categorization and system data clean-up. This data cleansing is imperative...  ...company. The role is hybrid and primarily remote . Stable Schedule: This role has... 

Robert Half

Audio Visual Technician Job at Robert Half

 ...Technician to join our team in Farmers Branch, Texas . This role is critical for ensuring the flawless operation of all audio and video conferencing systems, meeting rooms, and collaboration spaces. The ideal candidate will have strong technical skills, excellent... 

ESW Beauty

Global Sourcing & Purchasing Coordinator (Night Shift) Job at ESW Beauty

 ...Global Purchase and Sourcing Coordinator to join our growing team. Youll be responsible for sourcing, negotiating, and ordering packaging, fixtures, merchandise, and accessories from vendors around the world (specifically Asia) ensuring we deliver high-quality, on-brand... 

Express Employment Professionals Tysons, VA

Bilingual Customer Service Representative Job at Express Employment Professionals Tysons, VA

 ...Distributor of exterior and interior building products is looking for a Bilingual Inside Sales/Customer Service Representative to join its team....  ...-oriented mindset with a customer-first attitude Industry experience is a plus, but not required Bilingual (English/Spanish)... 

Blueprint Hires

Interior Designer Job at Blueprint Hires

 ...A California-based design firm that provides a wide range of architectural, interior, and planning services is seeking an Interior Designer to help them create exceptional...  ...(or progress towards) preferred. ~6+ years of experience at a design firm (with at least 3+ years of...