Clinical Trial Manager

2 weeks ago

Burlington, Massachusetts, United States Cardurion Pharmaceuticals, Inc Full time
Job Description

Cardurion Pharmaceuticals, Inc is seeking a highly motivated and experienced Clinical Trial Manager to join our Clinical Operations team. As a Clinical Trial Manager, you will be responsible for the successful execution of clinical trials, ensuring that all studies are conducted in accordance with regulatory requirements and company standards.

Key Responsibilities:

  • Lead the study execution team and collaborate with other functions to implement and execute clinical studies.
  • Develop and implement efficient clinical trial execution strategies, manage study budgets and timelines, and engage with external vendors.
  • Prepare and review study-related documents, including protocols, informed consents, and clinical study reports.
  • Manage CRO/Clinical Service Providers interactions, including sponsor oversight of operational functional activities.
  • Participate in the development, review, and implementation of departmental SOPs and processes.

Requirements:

  • BS or BA in a relevant scientific or health-related field.
  • A minimum of 5 years of related work experience in the pharmaceutical or biotechnology industry, with at least 3 years in a study management role.
  • Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies.
  • Experience in managing CROs and external vendors.
  • Demonstrated proficiency in MS Office (Outlook, MS Word, Excel, PowerPoint); MS Project a plus.

What We Offer:

  • Highly competitive package with healthcare coverage including medical, dental, and vision.
  • Fully funded Healthcare Savings Account for high-deductible PPO Plan.
  • 4 weeks paid time off annually.
  • 10 company-paid holidays and year-end shut down.
  • 401k (traditional and Roth offered) with company match.
  • A suite of Cardurion paid insurance coverage, including life insurance, short-term and long-term disability.
  • Flexible spending accounts for medical and dependent care expenses.

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