Clinical Data Strategy & Mgmt Associate Director (Remote)

Job Description

Clinical Data Standards Associate Director

Job Description

As a Clinical Data Standards AD working on the Clinical Data Strategy & Management team, you will be empowered to collaborate with cross functional teams and oversee Vertex's standards for data collection and cleaning and associated processes.

GENERAL POSITION SUMMARY:

• Ensures alignment with the CDSM Leadership Team, and Clinical Data Standards Committee (CDSC), establishes and drives strategy of Vertex's data standards and processes .
• Responsible for standards governance to ensure proper utilization of standards, adherence to standards processes, and the timely, thorough assessment of library enhancements and deviations
• Responsible for driving efficient, high quality and timely implementation of new standards
• Builds relationships across the Vertex organization and with FSP/CRO partners in support of the standards implementation

KEY RESPONSIBILITIES:

• Monitors industry-wide data standards and proposes concrete plans for implementation
• Leads cross-functional standards initiatives and helps to ensure coherence of standards initiatives across organization
• Develops and organizes review/feedback on new/modified standard eCRFs, CRF Completion Guidelines, edit checks, manual data reviews, etc. (global and therapeutic area-specific)
• Works collaboratively with cross-functional leadership to identify and develop streamlined and compliant CRFs in new therapeutic areas
• Responsible for strategy and developing standards library to ensure alignment to standards across systems
• Provides mentoring and technical guidance to Start Up Group
• Develops training strategy and ensures consistent training program for standards
• Conducts periodic review and development of metrics to assess standards utilization and development trends
• Serves as project manager for CDSC meetings (meeting scheduling, agendas, documentation and workflows), managing requests from deviations from standards content and processes

TECHNICAL/COMMUNICATION SKILLS:

• Has advanced knowledge of all clinical data standard library components and metadata across data collection, analysis and reporting
• In-depth knowledge of clinical data management and standard maintenance systems and processes, analysis and reporting principles
• Proven track record in identifying and implementing organization-wide initiatives, standards, and processes
• Proven track record in managing global, cross-functional standards and processes.
• Knowledge of medical and statistical terminology. Expert in pharmaceutical standard initiatives such as CDISC (ADaM, SDTM, CDASH and ODM), HL7, etc.
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem solving skills
• Entrepreneurial and innovative; takes measured risks; challenges the status quo
• Pragmatic and willing to drive and support change
• Comfortable with ambiguity
• Committed to understanding and meeting the needs of cross functional groups with streamlined data collection

EDUCATION AND EXPERIENCE:

• BS/BA or MS in a life science or analytical area
• 8-10 years of relevant work experience in the Biotech or Pharmaceutical Industry, or the equivalent combination of education and experience

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com