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Clinical Trial Manager

Employment Type Contract
Field of Work Clinical/Medical

 

Position Summary

The Clinical Trial Manager (CTM) functions as the clinical study team leader responsible for planning, organizing, and coordinating all operational aspects of the clinical study from protocol development through database lock. The CTM is also responsible for ensuring timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.

 

Responsibilities

  • Prepare and finalize project and study- related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND annual updates, Clinical summaries
  • Select investigators and study sites
  • Identify and respond to site and study related issues and recommending corrective actions and/or escalating to supervisor
  • Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process
  • Ensure that CRF data queries are resolved
  • Coordinate and manage Investigational Product including overall accountability and reconciliation
  • Prepare study budgets and timelines
  • Manage project timelines and vendor performance to meet departmental and corporate goals
  • Manage study budget and payment process for all clinical trial vendors including investigative sites
  • Monitor and track clinical trial progress and provide status update reports
  • Manage all clinical trial vendors
  • Responsible for selection of CRO study staff and coordinating training including documentation
  • Hire, train and oversee study field monitors (e.g., review of all trip reports) and provide guidance on site issues
  • Lead with minimal supervision in the planning of investigator meetings and making presentations, as required
  • Lead the review of clinical data at the CRF, data listing, and report table levels
  • Represent Clinical Operations at the project team level for individual studies, as appropriate
  • Partner with other research and development groups to achieve deliverables
  • Participate in Site Initiation Visits (SIVs) as required
  • Co-monitoring of regional sites for adherence to protocol and GCP as required
  • Travel as required to carry out responsibilities
  • Identify and escalate site, vendor and study related issues to supervisor, as appropriate
  • Participate in clinical and department settings, including attending additional meetings as required, interacting in a positive and professional manner
  • Manage Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals
  • Perform other duties as assigned

Required Qualifications and Background

  • BA/BS in related field
  • 5-7 years CRO or Pharmaceutical experience
  • CRO experience (highly desirable)
  • Oncology experience is a MUST (international preferred)
  • Experience in personnel management
  • Experience in CRO selection and management, including drafting request for proposals (RFPs), bidding process, etc.
  • Experience managing oncology clinical trials
  • Knowledge of FDA regulatory requirements and medical practice/techniques and terminology
  • Ability to work within a team, including leadership skills
  • Ability to organize and prioritize multiple tasks
  • Excellent communication and interpersonal skills
  • Attention to detail, organization, and problem-solving skills
  • Proficient in MS Office
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