Sponsor Contract Clinical Trial Managers

Category: CTM
Job #: 10888
Utilization: 100%
Location: Eastern US
Job Type: 1099
Therapeutics: Oncology (any role)

One of our Sponsors has an immediate need for full time contract CTMs in the Eastern US to work in their Oncology space. 100% Utilization needed (40 hrs/week during East Coast business hours). Must have at least 5 years of recent experience working as a CTM or PM for a CRO or Sponsor as well as experience with Oncology studies, budget management, and outsourced operations.

Job Responsibilities:
  • Manages and communicates to senior management overall clinical strategic operations plan for projects including timelines, internal and external resources/costs, key deliverables and key data issues
  • Convenes and leads cross-functional clinical teams
  • Develop study documents including case report forms, logs, and educational materials
  • Facilitate study progression by overseeing study activities
  • Provide leadership for study start-up, enrollment, and follow-up activities
  • Set and enforce project timelines with the assigned study team
  • Identifies and provides solutions and direction related to key cross-functional, sponsor-site, and sponsor-CRO clinical trial issues
  • Oversight and Direction to CROs and clinical vendors
  • Ensure all project team members are following applicable regulatory and standard operating procedures
  • Manage quality and regulatory compliance among clinical project team and investigational sites to maintain audit readiness
  • Plans, convenes, runs and presents study progress and known risks to Senior Leadership
  • In charge of the maintenance and overall clinical trial project budget up to 25%
  • Provides strategic planning expertise, drafts the operations components, including budget and resource estimates
  • Attend and provide information at monthly projections meetings and at weekly teleconferences/team meetings
  • Travel from 10-25% as necessary
Job Qualifications:
  • Must have at least 5 years of recent experience working as a CTM or PM for a CRO or Sponsor
  • Must have at least 5 years' experience working within Oncology studies (Device is a plus)
  • Must have at least 1 year of experience in budget management as well as working with CROs or outsourced operations
  • Bachelors Degree Preferred
  • Ideally located on the East Coast, but must be able to work business hours in the Eastern US Time Zone
  • 100% Utilization needed (40 hrs/week during East Coast business hours)
  • Some travel expected
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