Senior Clinical Trial Manager

Description Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, in alignment with defined plans and 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 is fully remote. Travel to headquarters for meetings may be required at the discretion of management. However, such instances are anticipated to occur fewer than six times per year. 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
• Support external vendor selection and management process and assists in the development of RFPs and vendor oversight plans
• 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 the 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
• Provide mentorship, review, assistance, or leadership for the development and writing of study protocols, study plans, CRFs, and informed consent forms Requirements
• BA/BS degree in Health or Life Sciences required; advanced degree preferred
• A minimum 8+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
• Exceptional communication and interpersonal skills
• Reliable, self-motivated, team player, creative problem solver
• Detail oriented with excellent organizational skills Ability to effectively manage multiple tasks and competing priorities in a fast-paced environment
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Proven mindset of proactive continuous improvement
• The salary range for this position is commensurate with experience Viridian Therapeutics, Inc.

provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws