Clinical Trial Manager

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Company: Aspire Health Science LLC
Location: Orlando, FL

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As a Clinical Trial Manager, you have a wide range of responsibilities. Primarily, you will work to achieve the most successful clinical trial possible. You will lead cross-functional teams with Project Management, Clinical Operations, and Regulatory Affairs, while understanding and managing client expectations. You will proactively identify, resolve/mitigate, and escalate risks or issues when necessary.

Qualifications & Position Requirements

Clinical Competencies

  • Minimum 6 years of project management / clinical coordination experience
  • Successful experience in monitoring clinical studies in a pharmaceutical or CRO
  • Experience in web-based data collection applications
  • Knowledge of key areas of Compliance
  • Knowledge in navigating the regulatory environment and filings for clinical trials

Non-Clinical Experience

  • College / University Degree, Biology background preferred
  • Strong communication skills as single point of contact for study teams
  • Excellent organizational skills with high attention to detail is required
  • Strong computer skills (spreadsheets, word processing, etc.) is required
  • Abiility to manage, prioritize, and routinely report progress on multiple projects and tasks
  • Strong skills in building and maintaining relationships with various stakeholders in clinical trial
  • Strong presentation skills to internal professionals and external collaborators

Responsibilities

  • Provide support and guidance to clinical trial site coordinators and Investigators regarding the clinical protocol, study conduct and recruitment activities.
  • Day-to-day management of the clinical trial sites and logistics.
  • Oversight of new clinical trial site start-up and activation
  • Oversight of recruitment initiatives and ensuring timely recruitment of trial participants.
  • Oversight of clinical trial site entry of study data into data management system.
  • Coordinating and supervising clinical and data monitoring teams.
  • Maintenance of Trial Master File.
  • Assuring compliance SOPs and local regulations, and CFR, ICH and GCP guidelines.

Job Type: Full-time

Salary: $70,000.00 to $85,000.00 /year

Benefits:

  • Health insurance
  • Paid time off
  • Dental insurance