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Engineering > Clinical Trial Manager

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103650.0000 122530.0000 142350.0000

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Short Description:

A Clinical Trial Manager (CTM) is responsible for overseeing the day-to-day operations of clinical trials, ensuring they are conducted according to protocol, regulatory requirements, and timelines. Their duties include managing clinical trial sites, coordinating with clinical research teams, monitoring study progress, and resolving any issues that arise during the trial. The CTM ensures that trial data is collected accurately, budgets are adhered to, and regulatory compliance is maintained. Strong project management, leadership, and communication skills are essential for success in this role, as Clinical Trial Managers play a critical role in ensuring the smooth execution and success of clinical studies.

Duties / Responsibilities:

  • Collaborate with Project Manager to set targets for clinical monitoring staff, and ensuring recording of trial in compliance with project goals.
  • Create and implement study-specific clinical monitoring tools and documents.
  • Create and oversee trial budget.
  • Identify, enlist and choose sites, and coordinate site management activities.
  • Coordinate and supervise clinical monitoring team.
  • Provide Clinical Research Associates with project-specific training and have regular meetings with them.
  • Record and share interactions with client, and act as their representative.
  • Arrange and oversee site visits.
  • Gather and examine trial documents.
  • Assure compliance SOPs and local regulations, and CFR, ICH and GCP guidelines.

Skills / Requirements / Qualifications

  • Education: Bachelor’s degree in nursing or life sciences.
  • Experience: 3+ years work experience for pharmaceutical company or related field.
  • Marketing: Proficient understanding of marketing and statistics.
  • Communication: Outstanding communication skills, both verbal and written.
  • Software: Proficient with Microsoft Office Word and Excel. Understanding of Electronic Data Capture (EDC).
  • Independent Work: Ability to work independently and prioritize duties.

Job Zones

  • Title:  Job Zone Four: Considerable Preparation Needed
  • Education:  Most of these occupations require a four-year bachelor's degree, but some do not.
  • Related Experience:   Most of these occupations require a four-year bachelor's degree, but some do not.
  • Job Training:  Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
  • Job Zone Examples:  Many of these occupations involve coordinating, supervising, managing, or training others. Examples include real estate brokers, sales managers, database administrators, graphic designers, chemists, art directors, and cost estimators.
  • SVP Range:  (7.0 to < 8.0)

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