Senior Clinical Trial Manager

Role Summary

The Senior Clinical Trial Manager leads the start-up and execution of global, outsourced clinical trials. This role manages CROs and vendors, develops study timelines and budgets, and oversees study management plans. It requires excellent global study management, strong oral and written communication, and the ability to collaborate across cross-functional teams, including remote and in-office colleagues in a fast-paced, small-company environment.

Responsibilities

• Clinical Trial Management & Execution – 50%
  • Support overall management of global clinical trials (planning, execution, closeout)
  • Monitor study progress, budgets, and timelines
  • Assist with planning and conduct of investigator meetings
  • Perform periodic visits to sites/CROs to assess study progress and protocol compliance
  • Review monitoring visit reports and ensure timely resolution of action items
  • Liaise with clinical sites and Investigators to maintain effective Sponsor-site relationships
• Vendor Oversight, Quality & Risk Management – 25%
  • Assist in evaluation, selection, and oversight of CROs, vendors, and consultants
  • Review and approve vendor-generated operational plans
  • Ensure audit readiness of trial documentation (including TMF)
  • Ensure compliance with GCP and regulatory requirements
  • Proactively identify, manage, and mitigate study risks
• Clinical Documentation & Operational Support – 25%
  • Participate in SOP preparation and review
  • Contribute to drafting and reviewing clinical documents (protocols, ICFs, IBs, reports, ASRs/DSURs, status updates)
  • Support meeting coordination, agendas, minutes, and metric tracking
  • Perform additional responsibilities as assigned by the line manager

Qualifications

• BA/BS required
• Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems
• Self-motivated, proactive, and able to prioritize and manage multiple projects simultaneously
• 7+ years of applicable clinical trial experience (5 years of vendor and CRO management) required
• Thorough knowledge of FDA, EMA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
• Experience in orphan indications will be favorably considered
• Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization
• Experience working on project teams is required
• Candidate should be a self-driven individual with skills in organization, building working relationships and communication
• Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company's drug development process, e.g., data management, biostatistics, regulatory, pharmacovigilance, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results

Additional Requirements

• Must be willing to travel both domestic and internationally