Join Viridian Therapeutics as an Associate Director, Clinical Data Management

About Viridian Therapeutics

At Viridian Therapeutics, we dedicate ourselves to developing best-in-class medicines for individuals living with autoimmune and rare diseases. Our team leverages expertise in antibody discovery and engineering to create a robust pipeline of investigational therapeutic candidates targeting well-validated conditions.

Position Overview

We are currently seeking an experienced Associate Director, Clinical Data Management to join our team in Waltham, MA. Reporting to the Senior Director, Clinical Data Management, you will define and lead our clinical data management strategy. This role involves overseeing the start-up and execution of multiple complex clinical trials in collaboration with CROs, as well as supporting upcoming submissions. While this position is based in our Waltham, MA headquarters, our office-based employees follow a hybrid schedule with remote work options at the discretion of management.

Key Responsibilities

• Drive and lead the development of all databases and eCRF design.
• Plan, develop, and implement UAT (user acceptance testing), data specifications, data entry guidelines, CRF completion guidelines, and related operational manuals.
• Execute data validation guidelines to ensure accurate data gathering from clinical studies.
• Review and provide expertise on all eCRF changes and make necessary database adjustments.
• Organize and direct initial study stages, including reviewing and signing off on eCRF, data validation, data review guidelines, and data management plans.
• Oversee and build strong relationships with multiple global CROs/vendors, managing coordination processes effectively.
• Ensure all data quality and timeliness of CDM deliverables are met, in alignment with business goals.
• Review, track, and report the status of data management projects to senior leadership.
• Manage clinical trial data queries and execute medical coding and SAE reconciliation.
• Maintain data integrity in compliance with GCP, relevant SOPs, and regulatory requirements.
• Collaborate with cross-functional stakeholders to meet project deliverables and timelines for clinical data acquisition and reporting.
• Develop and uphold data management SOPs and processes that align with business priorities.

Qualifications

• Bachelor’s degree in a scientific discipline (advanced degree preferred).
• Minimum 10+ years of experience in biotech/biopharma or CRO organizations.
• Extensive knowledge and experience in clinical data management.
• Direct experience with Data Management systems, Electronic Data Capture systems, and CDISC data standards.
• Knowledge of database and dictionary structures (e.g., MedDRA, WHO DRUG).
• Deep understanding of drug development, GCP regulations, and ICH guidelines.
• Strong written and verbal communication skills.
• Proven ability to manage multiple CROs/vendors.
• Commitment to ethical standards and data integrity.
• Proficient with Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint).

Compensation and Benefits

The salary range for this position is commensurate with experience. Viridian offers a comprehensive benefits package, including:

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

Equal Opportunity Employer

Viridian Therapeutics, Inc. provides equal employment opportunities and prohibits discrimination, harassment, or retaliation of any kind. We ensure reasonable accommodation is provided for individuals with disabilities in all aspects of the employment process. Please contact us to request accommodation.

Additional Information