Clinical Data Strategy & Mgmt Associate Director (Remote)

Job Description

Clinical Data Standards Associate Director

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 the 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.

Pay Range : $154,400 - $231,600

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.

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Remote working / work at home options are available for this role.