Description

At Viridian, we aim to advance new treatments for patients underserved by today’s therapies. 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. 

The Senior Manager Clinical Data Management is responsible for data management activities across multiple studies and programs from study start-up through study closure to ensure completion per established project team goals and objectives. The Senior Manager CDM will report to the Director of Clinical Data Management and will work closely with a cross-functional team, and contract research organizations (CROs) in a fast-paced, high growth environment to ensure that clinical data are complete, high quality, and delivered on time and within budget. This position will manage all data management activities from CRF design through database lock for in-house and outsourced clinical trials with minimal supervision. 

Job Responsibilities:

• Independently lead and represent Viridian Clinical Data Management (CDM) for all CDM activities of an assigned study or assigned studies across programs. 
• Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practice.
• Participates in the review, formation, and implementation of strategic initiatives and CDM development plans at the department level. 
• Ensures clinical data within EDC and other databases is of quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock Reviews and reconciles clinical database with external database/datasets.
• Mentors and manages clinical data managers, including hiring and retention, and providing performance evaluation feedback.
• Establish rapport and maintain positive, open communication with internal Viridian and external third-party teams.
• Effectively oversees contracted vendors, or vendor groups within CRO, to ensure data are complete, accurate and delivered within agreed timelines and within the budget.
• Will review upcoming CDM deliverables and forecast resourcing requirements as needed to execute ongoing and upcoming CDM activities within timeline and budget requirements.
• Initiate, facilitate, lead, and document all Viridian CDM project management activities, e.g., CDM deliverables, CDM meetings, meeting minutes.
• Participate in reviewing requests for proposals (RFPs) and providing budgetary, contractual and scope of work (SOW) feedback for the CDM functional area at Viridian.
• Works with cross-functionally, and with CROs to design and develop study documents including Case Report Forms (CRFs), CRF Completion Guidelines, Data Management Plan (DMP), Database Specifications, Electronic Edit Checks, and Data Transfer Specifications in CDISC format.
• Monitors and tracks the quality of all data management deliverables ensuring audit practices have been enacted to validate the quality and assurance of database content and supporting documents, from CROs as well as other external electronic data transfers.
• Proactively organizes ongoing cross-functional data reviews throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies.
• Serve as the primary point of contact for DM functional area at Viridian. 
• Leads data cut/database lock process and release of data for analyses.
• Plan and perform user acceptance testing of clinical database (CRF and edit checks).
• Review and approve data transfers and other deliverables from external sources.
• Lead cross-functional discussions to define data handling and database design standards.
• Generate and disseminate project status reports to management.

Participate in data management initiatives such as evaluating technology vendors (i.e. EDC, analytic tools), author and review SOPs, and establish data collection and reporting standards 

Requirements

Basic Qualifications:

• Bachelor's degree or equivalent in life science, computer science, or related discipline.
• 6 to 8 years of experience working within a pharmaceutical or CRO environment, with experience in managing Phase I, II and III studies, from start-up through closure.
• Demonstrated proficiency in various EDC Systems within the last 3 years.
• Demonstrated proficiency in the data management processes.
• Experience in managing external EDC vendors for Data Management.
• Understanding of Clinical Data Interchange Standards Consortium (CDISC), CDASH, and SAS® terminology.
• Understanding of the coding process and terms in MedDRA, WHODRUG and CTCAE.
• Thorough knowledge of applicable regulatory rules and guidelines.
• Excellent organizational skills and attention to detail.
• Effective communication and interpersonal skills.
• Able to set priorities and juggle multiple projects and demands.
• Able to think critically and independently and be a proactive problem-solver.
• Able to work independently while exercising initiative, flexibility, and sound judgment.

Viridian offers a flexible work environment. This position is a hybrid work model based out of our Waltham, MA location. 

Viridian offers a comprehensive benefits package including:

• Remote work with technology tools and infrastructure
• 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
• Company paid insurance 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 Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.