Senior Clinical Trial Manager

2 months ago


Philadelphia, United States Meet Full time

One of our innovative biotech clients focused on creating gene therapies for cardiovascular diseases is seeking a dedicated Senior Clinical Trial Manager (SCTM) to lead the planning, coordination, and management of clinical trials from study start-up through to clinical study reports. If you have a passion for clinical research and a strong background in global trial execution, we want to hear from you


Key Responsibilities:

  • Lead the development of study-specific documents, tools, plans, and procedures, including communication, monitoring, risk management, and vendor management.
  • Manage a cross-functional study team, ensuring timely information exchange and continuous assessment of operational performance.
  • Ensure trials are conducted in accordance with study protocols, SOPs, and regulatory requirements (ICH/GCP, country-specific regulations).
  • Perform quality control reviews of central clinical files and trial master files as needed.
  • Provide operational oversight to prioritize activities, monitor performance against timelines, and develop contingency plans.
  • Identify potential issues and risks, recommend solutions, and escalate concerns to the VP of Clinical Operations when necessary.
  • Oversee CROs and vendors to ensure adherence to quality standards and established study documents, timelines, and budgets.
  • Build strong relationships with investigators, KOLs, site staff, and CRO partners.
  • Champion continuous quality improvement by evaluating processes and recommending enhancements.
  • Participate in RFP/bid defense and selection of CRO/third-party vendors.
  • Support risk management and audit/inspection activities as needed.
  • Maintain trial postings on clinicaltrials.gov.


Qualifications:

  • BA/BS in health/life sciences or a related field.
  • 3+ years of drug development experience, especially in clinical trial management; experience in small biotech, cardiovascular, or gene therapy preferred.
  • Proven experience in developing global clinical operations strategies, including site monitoring and risk mitigation plans.
  • Prior global experience managing CROs, vendors, and consultants.
  • Strong knowledge of FDA/EMA regulations and ICH/GCP guidelines in clinical trials.
  • Leadership experience across all stages of clinical trial delivery (feasibility, start-up, enrollment, data collection, database lock, and close-out).
  • Ability to manage multiple competing priorities in a fast-paced environment.
  • Results-oriented with strong initiative and problem-solving skills.
  • Exceptional communication and interpersonal skills.
  • Proficiency in Microsoft Office Suite (Word, Outlook, Excel, Project), OneDrive, and SharePoint.


Special Considerations:

  • Some travel required to sites, vendors, and study-related meetings (approximately 40%).


If you’re ready to make a meaningful impact in clinical research and advance your career in a dynamic environment, apply today



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