Sr. Clinical Trial Manager

At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases.  We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions. 

Reporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the company’s strategic goals. The level reflects the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs. 

This role may be based in Waltham, MA, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.

Responsibilities (including, but not limited to):

• Accountable for project related efforts for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
• Supports external vendor selection and management process and assists in the development of RFP’s and vendor oversight plans.
• Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.
• Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines. 
• Project leadership of the cross-functional study team, including external team members, CROs and vendors.
• Plan, negotiate, and manage site budgets as well as facilitate site contracting process. 
• Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones. 
• May provide technical advice to team members. 
• Disseminate clinical program communications to all functional groups and leads program, study and team meetings. 
• Interact with clinical research investigators, Key Opinion Leaders and sites. 
• Interact with Senior Management to report on progress of milestones. 
• Oversight of study team and site training 
• Facilitation of Quality processes and Quality Assurance interactions for assigned project(s) 
• Management of study drug distribution and accountability processes and documentation 
• Oversight of study start-up, study management, data cleaning, and study closeout activities 
• Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival 
• Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.