Clinical Trial Manager

Key Responsibilities

• Lead and direct cross-functional teams and third parties/vendors with some supervision and support, to ensure compliance with study protocol and in accordance with the scope of work and with corporate timelines.
• Serve as the primary interface between the LuCIN sites and research partners.
• Identify areas of concern with study start up or conduct and escalate them to key stakeholders.
• Schedule, create agenda and lead meetings and project conference calls with vendors, investigators, and site staff to provide status updates, escalate issues, conduct training, and maintain accountability for deliverables.
• Manage project deliverables, including process via metrics and adherence to contractual agreement time, quality, scope, and cost deliverables.
• Review key study quality metrics and determine appropriate action in conjunction with study team.
• Develop and implement Study Plans (such as Communication Plans or Recruitment & Retention Plans) to support study management with vendor partners.
• Actively manage issues that could impact study progress and take actions or make recommendations to solve issues to support compliance.
• Independently develop in-depth analysis and projections or project timelines and financials for senior management.
• Establish and maintain excellent working relationships with investigators and study staff; conduct site teleconference and in person visits to ensure site performance.
• Develop and implement Study Plans (such as Communication Plans or Recruitment & Retention Plans) to support study management with vendor partners.
• Facilitate budget and contract negotiation per scope of work agreement and sponsor guidelines.
• Support study start-up and site activation to ensure deliverables are provided according to corporate and/or sponsor specifications, including delivery within deadlines.
• Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits.
• Track performance metrics in regard to enrollment and engagement.
• Offer strategic and creative advice for study communication and contribute to any LT partnership and study announcements.
• Contribute to LuCIN communication through newsletters, town halls and webinars.
• Participate in bid defenses and scope discussions as appropriate.
• Contribute to the annual LuCIN Community meeting and be part of LT initiatives and projects.

Requirements

• Bachelor’s Degree
• Three to five years of clinical trial experience with increasing levels of responsibility in the academic research, pharmaceutical, biotechnology, or CRO industry is required.
• Exposure to the clinical trial environment is required, project management role with contract and budget experience preferred.
• Therapeutic experience in autoimmune diseases and/or Lupus preferred.
• Possess excellent verbal and written communication skills.
• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods.
• Good team player with excellent negotiation and conflict resolution skills.
• Critical thinker, self-motivated, and quick learner.
• Organizational skills to work efficiently and manage multiple ongoing projects.
• Proficiency with MS Office suite (Word, Excel, PowerPoint, and Outlook).