Senior Manager, Clinical Data Standards: SDTM Lead

Immunocore; Gaithersburg, Northern (MD, KY); Hybrid; USD 122,000 - 203,000; Full time

Job summary

Immunocore is seeking a Senior Manager, Clinical Data Standards to lead the standardization of clinical data intake across EDC and non-EDC sources. You will own the Collection-to-SDTM pathway, ensuring data structures align with downstream SDTM/ADaM reporting, in support of multiple studies and CRO collaborations.

You will drive development of the Global Library, standard CRFs, and data transfer specifications while ensuring cross-study consistency and regulatory compliance with ICH-GCP, FDA,

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, or a related field.
• 8+ years in Clinical Data Management with at least 5 years focused on Data Standards and EDC Database Design.
• Advanced experience with Medidata Rave (Architect/Global Library) or Veeva CDB/Vault EDC.
• Proven track record of managing complex external data integrations (e.g., high-volume biomarker data, eCOA, or central lab data).
• Expert-level knowledge of CDASH and SDTM; ability to ensure collection supports reporting.
• Familiarity with regulatory guidelines (ICH-GCP, FDA, EMA).
• Experience in a small-to-mid-size biotech with high-level strategy and study-level execution.
• Master’s degree or CCDM/SAS Base Programmer certification.

Responsibilities

• Lead the development, maintenance, and governance of the Global Library for data collection, including standard CRFs, edit check specifications, and data integration plans.
• Ensure collection standards align with CDASH and SDTM for efficient mapping to SDTM.
• Govern versioning and implementation of the Global Library across the portfolio for cross-study consistency.
• Define and maintain standards for non-EDC data transfer specifications (DTS) with external vendor data.
• Collaborate with Clinical Operations and Vendor Management to ensure CROs adhere to data standards.
• Develop templates for Data Management Plans (DMP) and Data Transfer Agreements (DTA).
• Act as liaison to Clinical Programming and Biostatistics to support SDTM/ADaM reporting.
• Participate in governance forums to discuss impact on site burden and EDC builds.
• Ensure Traceability by Design from CRF to analysis-ready datasets.
• Provide expert oversight of EDC database builds (Medidata Rave, Veeva).
• Lead standards kick-offs for new programs and CROs.
• Perform standards compliance audits on study-level builds.

Skills

EDC Database Design

Medidata Rave

Veeva CDB/Vault EDC

CDASH/SDTM knowledge

Regulatory guidelines (ICH-GCP, FDA, E

External data integrations

Analytical skills

Attention to detail

Education

Bachelor’s degree in Life Sciences, Computer Science, or related field

Master’s degree or CCDM/SAS Base Programmer certification

Tools

SAS

SQL

Metadata Repository (MDR) tooling

Job description

Immunocore is seeking a Senior Manager, Clinical Data Standards to lead the standardization of clinical data intake across EDC and non-EDC sources. You will own the Collection-to-SDTM pathway, ensuring data structures align with downstream SDTM/ADaM reporting, in support of multiple studies and CRO collaborations.

You will drive development of the Global Library, standard CRFs, and data transfer specifications while ensuring cross-study consistency and regulatory compliance with ICH-GCP, FDA,