Clinical Trial Manager (CTM)

Clinical Trial Manager (CTM)

  1. Job Title

Clinical Trial Manager (CTM)

 

  1. Job Status

Full Time

 

  1. Job Summary

The Clinical Trial Manager (CTM) manages at least one primary project, and depending on scope and phase of project, may support multiple projects. The CTM provides project management expertise throughout the development and implementation of clinical studies. Interacts with various study support groups and the business unit in order to assist in clinical strategy, the development of study plans, and project deliverables. The CTM may also be assigned to other non-trial related activities such as process and procedure teams. May support and mentor junior-level project managers.

 

  1. Job Details
  • Organize, communicate and evaluate team objectives for clinical studies
  • Provide leadership in developing study-related documents, which might include study plans, investigator files and informed consent documents
  • Review invoices from study vendors, institutional review board approvals, clinical study agreements and monitoring reports
  • Facilitates site selection process by conducting meetings with appropriate departments and individuals to review and revise draft site list as necessary, and by communicating the final site list to team members
  • Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines
  • Identify resource needs and elevates/resolves resource constraints with management
  • Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process
  • Oversees compliance to study requirements; Reviews compliance to protocol and elevates critical protocol deviations
  • Works with Study Team to coordinate activities for all milestones
  • Provides study-specific training to internal team members and site personnel.
  • make sure that good clinical practice (GCP) and regulatory compliance are maintained
  • maintain good relations with clinical sites, physicians, medical research staff and outside consultants.
  • serve as liaisons between internal team members, investigative sites and the clinical research organization.
  • resolve project conflicts and issues

 

  1. Candidate Requirements (External)

Primary Qualifications:

A graduate degree or undergraduate degree

  • Undergraduate degree with 7 years experience in clinical research and at least 3 years as a full-service project manager

OR

  • Graduate degree with 5 years experience in clinical research and at least 2 years as a functional team lead role or full-service project manager

 

Additional Qualifications:

  • Experience in Oncology therapeutic area
  • Proficiency with Microsoft Office and use of electronic document templates
  • Time management and project management skills are essential
  • Knowledge of FDA guidelines and regulations
  • Experience or background in working within the pharmaceutical industry, awareness of compliance issues and guidelines around medical education and publications
  • Ability to manage multiple projects, solve problems, deliver on commitments and work with multidisciplinary teams
  • Independent, self-starting individual with a demonstrated ability to thrive in smaller, biopharma environment is required
  • Strong interpersonal and organizational skills and excellent verbal and written communication skills are required
  • Excellent collaboration skills with strong attention to detail and the ability to multitask and manage complexity
  • Demonstrates ability to influence others to achieve positive results and collaboration
  • Good understanding of project management and must possess strong problem-solving and leadership skills
  • Very well-rounded in all aspects of a clinical operations
  • Reads, writes and speaks fluent English