Senior Lead, Clinical Data Standards & SDTM Governance

Immunocore; Radnor (Delaware County); On-site; USD 121,500 - 202,500; Full time

Job summary

Immunocore is looking for a Senior Manager for Clinical Data Standards based in Radnor, PA. This role serves as a strategic lead for standardizing clinical data intake from various sources, ensuring integration and quality across studies.

The ideal candidate will have over 8 years of experience in Clinical Data Management, with substantial experience in EDC database design. Strong knowledge of CDASH, SDTM, and regulatory guidelines are essential. Join Immunocore and be a part of pioneering innovative medicines!

Qualifications

• 8+ years in Clinical Data Management with focus on Data Standards.
• Advanced experience with Medidata Rave or Veeva EDC required.
• Excellent analytical skills and attention to detail.

Responsibilities

• Lead standardization of clinical data intake streams.
• Develop templates for Data Management Plans and Agreements.
• Ensure adherence to company data standards across third-party providers.

Skills

Clinical Data Management

Data Standards

EDC Database Design

Attention to detail

Analytical skills

Education

Bachelor's degree in Life Sciences or related field

Master’s degree or relevant certification

Tools

Medidata Rave

Veeva CDB/Vault EDC

SAS

SQL

Job description

Immunocore is looking for a Senior Manager for Clinical Data Standards based in Radnor, PA. This role serves as a strategic lead for standardizing clinical data intake from various sources, ensuring integration and quality across studies.

The ideal candidate will have over 8 years of experience in Clinical Data Management, with substantial experience in EDC database design. Strong knowledge of CDASH, SDTM, and regulatory guidelines are essential. Join Immunocore and be a part of pioneering innovative medicines!