Lead Clinical Trial Operations Manager

2 weeks ago

Connecticut, United States Patel Consultants Corporation Full time

Position Overview:

As the Clinical Trial Manager (CTM), you will be responsible for the operational oversight of the local aspects of clinical trials. Your leadership will ensure that recruitment goals, timelines, budgets, and quality standards are met in accordance with both internal and external expectations.

Key Responsibilities:

  • Lead the local trial team to maintain the integrity of trial execution and ensure patient safety.
  • Plan, conduct, and report on the local and regional components of trials in compliance with regulatory standards.
  • Collaborate with various stakeholders, including suppliers and investigational sites, to facilitate smooth trial operations.
  • Represent the organization in meetings with regulatory agencies and other external parties.
  • Manage multiple assignments concurrently, balancing conflicting priorities effectively.

Trial Management:

In partnership with the Site Monitoring Lead and Clinical Research Associates (CRAs), you will serve as the primary contact for investigators and site personnel, ensuring seamless communication and coordination.

Essential Skills:

  • Exceptional communication abilities within complex, cross-functional environments.
  • Strong project management and stakeholder engagement skills.
  • Comprehensive understanding of the clinical development process and regulatory requirements.

Technical Proficiency:

Demonstrated expertise in all facets of clinical trial operations, with knowledge in relevant therapeutic areas considered advantageous. You will manage trial complexities, including protocols, subjects, sites, and suppliers, across multiple studies.

Leadership and Strategic Insight:

Your ability to navigate complex situations, resolve conflicts, and influence stakeholders at all levels will be critical. You will embrace cross-functional initiatives and apply innovative solutions to identify risks and develop mitigation strategies.

Travel Requirements:

Willingness to travel domestically as needed (approximately 10-20% of the time).

Qualifications:

A Bachelor's degree with a minimum of 6 years of experience in clinical research, preferably within the pharmaceutical sector; or a Master's degree or PharmD with at least 4 years of relevant experience; or a PhD or MD with a minimum of 2 years in clinical research.

Core Competencies:

  • Clinical Trial Monitoring
  • Clinical Operations
  • Good Clinical Practice (GCP)

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