The Data Standards Manager III serves as a primary architect of data integrity, overseeing the strategic implementation of CDISC standards across complex clinical development programs. This role is responsible for ensuring that clinical trial data is collected, mapped, and reported with absolute precision, facilitating seamless transitions from eCRF design to regulatory submission. By maintaining a robust metadata repository and providing governance over data assets, this individual ensures that scientific discoveries are supported by high-quality, submission-ready data packages.
location: Telecommute
job type: Contract
salary: $65.00 - 71.02 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Standardization & Governance: Lead the development and maintenance of global clinical data standards, providing expert governance over the metadata repository and ensuring consistent application of terminology across the enterprise.
- SDTM Conformance Mapping: Drive the creation and rigorous review of SDTM conformance mapping specifications, applying TAUG and industry-best practices to ensure data remains compliant and traceable.
- eCRF Strategic Design: Perform critical reviews of eCRF designs to ensure proactive alignment with CDASH and SDTM standards, identifying and correcting structural flaws before data collection commences.
- Regulatory Validation: Execute and oversee validation protocols using tools such as Pinnacle 21, resolving complex issues and documenting technical justifications within the Clinical Study Data Reviewer's Guides.
- Cross-Functional Leadership: Represent the Data Standards group in multidisciplinary study teams, acting as a diplomatic and persuasive advocate for data integrity among statisticians, programmers, and clinical development leads.
- End-to-End Traceability: Manage the lifecycle of data from collection to reporting, ensuring that all metadata and trial design domains (Trial Design Model) meet the stringent requirements of eCTD submissions.
qualifications:
Required:
- Education: Master of Science degree with 8 years of relevant clinical research experience, or a Bachelor of Science degree with 12 years of relevant experience.
- Subject Matter Expertise: Expert-level proficiency in CDASH, SDTM, define.xml, and Controlled Terminology.
- Submission Track Record: Proven experience in mapping and converting legacy data into SDTM domains for eCTD submissions, including a minimum of two successful, high-stakes regulatory submissions.
- Regulatory Knowledge: Comprehensive understanding of international regulations and GxP guidance associated with clinical data standards.
- Technical Tools: Advanced experience with metadata repository technology and industry-standard validation tools (e.g., Pinnacle 21 Enterprise).
- Experience leading data standards governance initiatives within a large-scale Biotech or Pharmaceutical environment.
- Advanced ability to translate complex logical arguments regarding data architecture into actionable strategies for non-technical stakeholders.
skills: CDISC, SDTM, Categorical Data Analysis, Good Clinical Practice (GCP), Life Cycle Management Regulatory Perspective, Electronic Common Technical Document (eCTD)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
