Madrigal Pharmaceuticals logo
Madrigal Pharmaceuticals

Madrigal is focused on developing therapeutics to improve the lives of patients with metabolic and fatty liver diseases.

Associate Director – Clinical Site Management and Monitoring Oversight

DirectorDirectorFull TimeRemoteSeniorTeam 51-200H1B SponsorCompany SiteLinkedIn

Location

California

Posted

44 days ago

Salary

$172K - $211K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglishVault

Job Description

• Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program to ensure sponsor oversight of outsourced trials • Utilizing a risk-based approach, perform remote and on-site Monitoring Oversight Visits within a regional US territory • Document and communicate visit findings to CRO partners and Madrigal stakeholders; assess trends across studies and sites; and manage mitigations, resolutions and CAPAs to remediate identified issues as needed • Provide sponsor support to CRAs and sites at Site Qualification Visits, Site Initiation Visits, and Monitoring Visits • Develop and foster relationships with Madrigal sites within a regional US territory to drive compliance and support optimal performance • Serve as a Madrigal escalation resource and partner with the CRO, trial team and/or sites to resolve compliance, data and/or monitoring issues • Build and manage a group of high-performing Madrigal CRAs within a regional US territory (West, Central or East) that monitor Madrigal trials • Contribute to the creation of controlled documents (SOPs, Work Instructions, Job Aids, Templates, Forms) pertaining to Monitoring, and customize for insourced trials • Strategically allocate internal CRA resources to studies and sites

Job Requirements

  • Bachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree a plus
  • 10+ years of clinical operations or monitoring experience, with a minimum of 2+ years in a field CRA role, and additional 2+ years in a prior CRA Manager or Monitoring Oversight (of outsourced monitoring) role
  • Ability to travel 50%, on average
  • Proven track record of successfully managing CRAs across various phases and therapeutic areas
  • Experience with developing training programs, systems and tools for CRAs
  • Demonstrated ability to influence peers within a matrixed and fast-paced organization
  • Strong strategic thinking, problem-solving, and influencing skills
  • Recent experience with Veeva Vault systems (TMF, CTMS)

Benefits

  • Flexible paid time off
  • Medical, dental, vision and life/disability insurance
  • 401(k) offerings (i.e., traditional, Roth, and employer match)
  • Voluntary benefits like supplemental life insurance, legal services, and other offerings
  • Mental health benefits through our Employee Assistance Program

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