Deliver clinical milestones on time and within scope
Independently leads the cross-functional study team in the development and execution of complex clinical trials and is accountable both regionally and globally to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget
Job Summary
Independently leads the cross-functional study team in the development and execution of complex clinical trials and is accountable both regionally and globally to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget.
Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
Matching Summary
Independently leads the cross-functional study team in the development and execution of complex clinical trials and is accountable both regionally and globally to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget.
Salary
Base: $115,500 - $169,400; Bonus/Equity: company bonus; Benefits: comprehensive benefit program
Skills & Requirements
Must-have
lead cross-functional study team
develop and execute complex clinical trials
deliver clinical milestones on time and within scope
manage trial-level risks and budget
manage TPO qualification and oversight
ensure trial master file is inspection ready
Nice-to-have
demonstrate credibility and influence
anticipate and resolve complex problems
drive continuous improvement activities
act as a coach for peers and new CDTLs
Key Requirements
Bachelors or University degree (scientific or health-related field preferred)
5 years clinical research experience or relevant experience
Applied knowledge of project management methodology
Demonstrated ability to lead and work effectively cross-culturally
Previous experience working in cross-functional teams