BridgeBio

Hope Through Rigorous Science

Senior Clinical Trial Manager – Imaging Study

Clinical ResearchClinical ResearchFull TimeRemoteTeam 201-500Since 2015H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

5 days ago

Salary

$162.7K - $191K / year

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

• Leads the Clinical Study Team for assigned projects; may lead one or more clinical studies, from concept to protocol, and achieve corporate objectives and key milestones such as First Patient In, Interim Analysis, Database lock, etc. • Manage external vendors and contract research organizations, may manage internal resources such as Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs) • Prepare/Review/Approve study documents such as the Monitoring Manual, Study Operational Manual, Source Data Verifications Plan, and Laboratory Manual • Coordinate and design study materials such as CRFs, patient diaries, study participation cards, and source documents. • Manage operational activities at the study level and monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to GCP, Standard Operating Procedures (SOPs), and study protocols • Negotiate and manage vendor work agreements and site contracts

Job Requirements

  • Bachelor’s degree in a scientific discipline or equivalent is required, and an advanced degree is preferred
  • Requires at least eight years of biopharma industry experience (relevant clinical trials experience, in the biotechnology, pharmaceutical, CRO, medical device industry) with at least two years managing clinical trials
  • Must have vendor management experience in clinical operations/development
  • Strong verbal and written communication skills, can communicate strategic direction and relevant context so that employees at all levels understand their role in achieving success
  • Ability to build and maintain strong working relationships within the department and cross-functionally to meet a project or corporate goal
  • Experience with Microsoft Office Suite required (Word, Excel, Project, Outlook)
  • Must be able and willing to travel periodically

Benefits

  • Market leading compensation
  • 401K with 100% employer match on first 3% & 50% on the next 2%
  • Employee stock purchase program
  • Pre-tax commuter benefits
  • Referral program with $2,500 award for hired referrals
  • Comprehensive health care with 100% premiums covered - no cost to you and dependents
  • Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
  • Hybrid work model - employees have the autonomy in where and how they do their work
  • Unlimited flexible paid time off - take the time that you need
  • Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
  • Flex spending accounts & company-provided group term life & disability
  • Subsidized lunch via Forkable on days worked from our office

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