Study Start Up Associate Jobs in Perth Amboy, NJ

Position Title: Clinical Trial Manager, Lupus Therapeutics

Reports to: Director of Clinical Operations

Location: Hybrid (NYC) or Remote

Salary Range: $85,000 - $115,000

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, conduct and management of a North American-based clinical trial network, the Lupus Clinical Investigators Network (LuCIN), as well as Patient Engagement and Education efforts to foster clinical research for the development of new therapies and clinical care approaches for the diverse lupus community.

Position Overview

The Lupus Therapeutics Clinical Trial Manager will manage a variety of pharma/biotech and research-led clinical research projects. As Clinical Trial Manager, you will be a liaison to your partners, establishing productive relationships for successful studies, ensuring questions are answered and issues are resolved proactively in partnership with colleagues, partners, and other stakeholders. You will be responsible for multiple studies and ensure there is optimal quality, communication, strategic input and management of all LT project deliverables. As a leader on projects, you will provide metrics, guidance and feedback to the partner and site teams to help improve overall performance.

The position immediately reports to the Director of Clinical Operations and can be hybrid in the NYC area or Remote. Please note for candidates not based in NYC, the starting salary may be adjusted based on location.

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.

• Conduct site feasibility and evaluate site performance in support of site selection.
• 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).
• Limited travel as required (North America) for site visits, conferences and team meetings.

Interested candidates should submit a cover letter and CV/resume.

The Lupus Research Alliance, Inc. is an Equal Opportunity Employer, committed to equal opportunity for all regardless of race, ethnicity, color, ancestry, national origin, citizenship, religion, sex, sexual orientation, gender identity/orientation/preference, class or socioeconomic status, marital status, age, ability, or Veteran status.