Clinical Trial Lead/Sr Clinical Trial Lead - WHDx

Location
United States
Posted
Jan 12, 2022
Required Education
Bachelors Degree
Position Type
Full time

Leads the clinical monitoring team (Clinical Research Associates [CRAs] and In-house Clinical Research Associate [IHCRAs]), to ensure that projects are completed in accordance with the Task Order, client, and Health Decisions expectations.

MAJOR RESPONSIBILITIES:

  • Oversees the following tasks, if applicable:
    • feasibility and investigator selection
    • monitoring projections, including resource and visit projections
    • monitoring report review
    • study training for clinical monitoring team
    • overall site and CRA metrics
    • site assignments
    • subject closeout
  • Assist project management with resource and utilization assessments, timeline adherence, quality assurance, and financial adherence as it pertains to clinical monitoring team activities.
  • Act as secondary sponsor contact.
  • Act as a resource and point of escalation for protocol and process questions from clinical monitoring team members.
  • Ensure site and in-house monitoring is occurring according to the monitoring plan and study timelines.
  • Create and modify study documents.
  • Present at Investigator Meetings.
  • Review and approve expense reports.
  • Plan and facilitate site and CRA meetings.
  • Provide study status updates to the PM and escalate study issues.
  • Provide feedback on clinical team member performance to Line Managers.
  • Assists project manager with other tasks as assigned.
  • All Clinical Research Associate responsibilities.

ADDITIONAL RESPONSBILITIES OF Sr CTL:

  • Assist with managing the project budget.
  • Independently manage project vendors.
  • Recruit, train,retain and manage performance of direct reports.

QUALIFICATIONS: 

  • BA/BS degree (preferably in a life science) and relevant experience.
  • A minimum of 5 years of experience as a CRA or clinical trial lead.
  • Progressive experience in the conduct of clinical research including ICH-GCP requirements, drug/device development process, and regulatory compliance.
  • Strong leadership skills and demonstrated ability to manage others.
  • Strong mentorship skills and advanced monitoring skills to ensure quality of monitoring for the clinical team.
  • Proficient computer skills, especially in Microsoft Office, and the ability to learn other applications.
  • Excellent written, oral communication, organization and presentation skills.
  • Read, write and speak fluent English; fluent in host country language.

ADDITIONAL QUALIFICATIONS OF CTL Sr CTL

  • A minimum of 7 years of experience as a CRA or clinical trial lead.

For Sr CTL:

  • Must effectively manage any direct reports.
  • Must demonstrate proficiency with the study timeline, and other management tasks.