Associate Director, Clinical Data Management

Waltham, MA, United States

Description

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.

Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex trials with a CRO and supporting upcoming submissions. The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs.

This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. Remote work is allowed, and the frequency is at the discretion of management.

Responsibilities (including, but not limited to) :

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/guidelines

Develop and execute data validation guidelines and measures to ensure accurate data gathering from clinical studies

Review and provide expertise on all eCRF changes, respond accordingly to make resulting database changes

Organize and direct the initial stage of the studies, review and sign off on various items such as eCRF, data validation, data review guidelines, and data management plans

Oversee and build strong sustainable relationships with multiple global CROs/vendors along with managing the process and coordination of each

Accountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the business goals; Coordinate with all functions to drive data cleaning

Review, track, and report status of all data management project(s) to senior leadership

Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation

Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF)

Partner with cross functional key stake holders to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting; Serve as internal expert on data management with vendors

Develop data management SOPs and processes that align and address business priorities; Contribute to cross-functional SOP development

Uphold a reputation for data integrity and compliance

Requirements

Requires a Bachelor’s degree within a scientific discipline (advanced degree a plus) with a minimum of 10+ years of experience within biotech/biopharma and/or CRO organization

Extensive knowledge and experience in clinical data management

Direct experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards

Extensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans

Comprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG)

Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations

Demonstrated experience in managing multiple CROs/vendors

Demonstrated strong written and verbal communication skills

Proven mindset of proactive continuous improvement

Efficient independent worker with ability to focus and drive for results

Strong attention to detail

Ability to work in a fast paced-environment and to handle multiple tasks

Strong commitment to ethical standards

Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)

The salary range for this position is commensurate with experience

Viridian offers a comprehensive benefits package including:

C ompetitive 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.

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