Green Key Resources

Clinical Trial Manager

Green Key Resources United States
Green Key Resources

Clinical Trial Manager

Green Key Resources United States
3 weeks ago 171 applicants

See who Green Key Resources has hired for this role

Summary

The Clinical Trial Manager (CTM) is responsible for leading one or more Study Management Teams (SMTs).

The CTM is responsible for the day-to-day management of a clinical trial and oversight of vendors, clinical monitors and clinical trial sites. The CTM is also accountable for ensuring high quality deliverables are within timelines and budget.

Responsibilities

  • Responsible for the day to day management and oversight of assigned operational aspects, such as CRO/vendor management, drug supply management, clinical sites, etc.
  • Lead cross-functional SMT meetings
  • Support the Program Lead during the Protocol Development process
  • Participate in protocol, eCRF development, and Clinical Study Report preparation, as appropriate
  • Conduct protocol and site feasibility assessments
  • Identify study risks, develop and implement mitigation strategies; proactively manage the study and associated risks through key risk and performance indicators.
  • In collaboration with Clinical Procurement and Outsourcing, provide leadership in the selection of vendors, including CRO, central lab, imaging, etc.
  • Oversee the development and review of study-related documents (e.g., eCRFs, Study Reference Binder, Study Management Plan, Vendor Management Plan, Risk Management Plan, eCRF Completion Guidelines, etc.)
  • Provide drug supply assumptions to the clinical planning team
  • Develop and maintain study timelines, enrollment dashboards, and budgets
  • Serve as a liaison and resource for clinical trial sites
  • Oversee the creation and maintenance of the Trial Master File
  • Perform site initiation, routine monitoring and close-out visits, as well as co-monitoring with CRAs as needed
  • Review site visit reports
  • Participate in the development, review and implementation of departmental SOPs and processes

Qualifications

  • Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
  • Minimum 4-6 years clinical trial experience with demonstrated ability to lead study teams
  • Working knowledge of ICH Good Clinical Practice guidelines
  • Experience with international trials is preferred
  • Able to handle multiple tasks and deadlines
  • Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
  • Highly effective verbal and written communication skills
  • Must have the ability to build and maintain positive relationships with management, peers and clinical sites
  • Experience using computer applications including spreadsheets, email, word-processing software and web-based systems
  • Willing to travel domestically and internationally

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Research, Analyst, and Information Technology

  • Industries

    Staffing and Recruiting

Referrals increase your chances of interviewing at Green Key Resources by 2x

See who you know

Get notified about new Clinical Trial Manager jobs in United States.

Sign in to create job alert

Similar jobs

People also viewed

Looking for a job?

Visit the Career Advice Hub to see tips on interviewing and resume writing.

View Career Advice Hub