Description

At Viridian, 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.

Reporting to the Sr. Director, Clinical Excellence Operations the Senior Manager/Associate Director, Records Management will be responsible for expertise, oversight, implementation of systems and process improvement and training related to the trial master file (TMF) and eTMF systems, and other clinical trial documentation. The incumbent is responsible for records management activities across all therapeutic areas of development at Viridian Therapeutics. The Associate Director of Records Management will provide direct management and leadership for individuals in the records management team. The incumbent will ensure GCP compliance and inspection readiness related to clinical records management within the clinical operations department. 

This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

•        Provide leadership to the records management team fostering a collaborative team culture while ensuring goals and timelines are met with quality, in compliance with SOPs and regulatory guidelines. Identifies and/or anticipates risks and plans accordingly for mitigation and escalates issues to management as necessary.
•        Acts as the clinical operations TMF/eTMF subject matter expert by providing expertise, best practices related to clinical records management, system implementation and training development.
•        Provide management and oversight of the TMF/eTMF, including implementation of systems, oversight plans, process documents, tools and templates related to TMF/eTMF.
•        Perform routine sponsor oversight reviews of study TMF/eTMF to ensure compliance to quality records management deliverables across the entire Viridian Therapeutic profile.
•        Management of the CRO/Vendors and risk mitigation strategic input to ensure goals and deliverables are met with quality in the contracted scope of work and in compliance with ICH/GCP and regulatory guidelines.
•        A contributing member of cross-functional study teams ensuring GCP compliance and implementation of the TMF oversight plan quality goals and making sure timelines are met, incompliance of SOPS and regulatory guidelines, while fostering a collaborative team culture.
•        Assist with site/sponsor audits and regulatory inspections, assisting with in-house and site inspection readiness planning and training. 
•        Support of Clinical Operations projects, infrastructure, training, and processes (e.g. SOP development and review, management of clinical systems, oversight of clinical metrics tracking and reporting), inspection readiness efforts and audit-ready Trial Master Files reviews (internal and at CRO).
•        Management of the eTMF migration process when the TMF is held by an external vendor to ensure the delivery of a complete and accurate TMF.
•        Travel required: up to 10% (for business meetings at Viridian office, eTMF audits at CRO/Vendors, and industry conferences)

Requirements

•        BA/BS degree in Health or Life Sciences required, advanced degree preferred.
•        A minimum 5-6+ years (Sr. Manager)/8+ years (Associate Director) of relevant experience in Clinical Operations roles within the Pharmaceutical and/Medical Device Industry, with heavy concentration within clinical trial management and monitoring.
•        A minimum of 5+ years’ experience with trial master file/records management, oversight, maintenance, document review and QC is required
•        A minimum of 2+ years of experience as a manager/leader
•        Health authority inspection experience is preferred
•        Exceptional collaboration, communication, and interpersonal skills
•        Demonstrated ability to effectively manage external vendors & CROs
•        Advanced proficiency in Microsoft Office and Microsoft Project
•        Reliable, self-motivated, team player
•        Detail oriented with excellent organizational skills
•        Ability to effectively manage multiple tasks and competing priorities

Viridian offers a comprehensive benefits package including:

• Competitive pay and stock options for all employees
• Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
• Fertility and mental health programs
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company vest
• Employee Stock Purchase plan
• Generous vacation plan and paid company holiday shutdowns
• Various mental, financial, and proactive physical health programs covered by Viridian
   

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. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.