Associate Clinical Trial Manager, Lupus Therapeutics (Contract basis)

Location: Remote

Remuneration: $100/hour, up to 25 hours per week

Background

The Lupus Research Alliance (LRA) is the world’s leading non-governmental, non-profit funder of lupus research. Over the past 20 years, the LRA has invested over $250 million in lupus research in more than 525 research and clinical studies. In 2018, the LRA established a clinical affiliate organization, Lupus Therapeutics (LT), which is responsible for the coordination, and management of a North American-based clinical trial network, the Lupus Clinical Investigators Network (LuCIN), facilitating clinical trial conduct through operational and advisory services, as well as overseeing Patient Engagement and Equity efforts for the LRA. The primary objective of LT is to foster clinical research for the development of new therapies and clinical care approaches for the diverse lupus community.

Opportunity Overview

Lupus Therapeutics seeks a fixed-term, contract-based Associate Clinical Trial Manager to support the management of a variety of biopharmaceutical clinical research projects. The role will be a liaison to partners, establishing productive relationships for successful studies, ensuring questions are answered and issues are resolved proactively in partnership with colleagues, partners, and LuCIN centers. This role will support multiple studies and ensure there is optimal quality, communication, strategic input and management of LT project deliverables.

The contract term will be through December 31, 2024 with the potential for renewal or full-time employment based on business need. The point of contact for the opportunity will be the Director of Clinical Operations, who will oversee the deliverables and provide any needed support and resources.

Key Deliverables

• Support clinical trial management, act as a project lead and ensure compliance with study protocol and in accordance with SOPs, the scope of work, and corporate timelines.
• Serve as an interface between the LuCIN sites and sponsor partners.
• Support study start-up and site activation to ensure deliverables are provided according to corporate and/or sponsor specifications, including delivery within deadlines. Identify areas of concern with study start up or conduct and escalate them to key stakeholders.
• Schedule, conduct and complete follow-up for meetings and project conference calls with vendors, investigators, and site staff to provide status updates, escalate issues, conduct training, and maintain accountability for deliverables.
• Support 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. Complete data and metrics tracking for key deliverables and reporting for partners, escalating issues, trends, quality concerns or recruitment challenges.
• 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.
• In conjunction with management, support in-depth analysis and projections or project timelines and financials.
• Establish and maintain excellent working relationships with investigators and study staff; conduct site teleconferences and prepare accurate and timely reports from all site interaction visits.
• Identify, select, and monitor performance of investigational sites for clinical studies.
• Track performance metrics in regard to enrollment and engagement.
• Participate in project, program, functional area and team meetings as required.
• Support corporate and network initiatives, events and programs.

Requirements

• Bachelor’s Degree
• Two to four years of clinical trial experience in the academic research, pharmaceutical, biotechnology, or CRO industry is required.
• Exposure to the clinical trial environment is required, clinical trial management 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).
• Limited travel may be required (North America)