Senior Manager, Clinical Data Standards

Scorpion Therapeutics; Radnor (Delaware County); On-site; USD 122,000 - 203,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced Clinical Data Manager to lead data standards and EDC design across our development portfolio. You will govern the Global Library, ensure CDASH alignment, and optimize SDTM mappings while coordinating with Clinical Operations, vendors, and cross-functional teams.

The role requires advanced Medidata Rave/Veeva experience, a strong background in data integration, and a track record of delivering compliant, inspection-ready data solutions in biotech

Qualifications

• 8+ years in Clinical Data Management with 5+ years in Data Standards and EDC design.
• Advanced experience with Medidata Rave Architect/Global Library or Veeva CDB/Vault EDC.
• Expert knowledge of CDASH and SDTM workflows.
• Proven experience managing complex external data integrations.
• Familiarity with ICH-GCP, FDA, EMA.
• Experience in small-to-mid-size biotech with strategy-to-execution ability.
• Master’s degree or CCDM/SAS certification.

Responsibilities

• Lead development, maintenance, and governance of Global Library for data collection.
• Align collection standards with CDASH and optimize mapping to SDTM.
• Govern Global Library versioning and cross-study consistency.
• Define non-EDC data transfer specifications for vendor ingestion.
• Collaborate with Clinical Operations and vendors to ensure third-party adherence.
• Develop templates for Data Management Plans and Data Transfer Agreements.
• Liaise with Clinical Programming and Biostatistics to support SDTM/ADaM reporting.

Skills

CDASH expertise

SDTM knowledge

Medidata Rave

Veeva Vault

Data integration

Education

Bachelor’s degree in Life Sciences or related field

Master’s degree or CCDM/SAS certification

Tools

Medidata Rave Architect/Global Library

Veeva CDB/Vault EDC

SAS

SQL

Job description

Key Responsibilities:

• Lead the development, maintenance, and governance of the Global Library for data collection (standard CRFs, edit check specifications, data integration plans).


• Ensure collection standards align with CDASH and are optimized for efficient mapping to SDTM.


• Govern Global Library versioning and implementation across the portfolio for cross-study consistency.


• Define/maintain non-EDC data transfer specifications (DTS) for standardized vendor ingestion (labs, PK, eCOA, imaging).


• Collaborate with Clinical Operations and Vendor Management to ensure third-party adherence from study startup.


• Develop standardized templates for Data Management Plans (DMP) and Data Transfer Agreements (DTA).


• Liaison to Clinical Programming and Biostatistics to ensure collection supports the downstream reporting strategy (SDTM/ADaM).


• Incorporate “Traceability by Design” into CRFs.


• Provide oversight of EDC database builds (e.g., Medidata Rave, Veeva).


• Lead standards kick-offs; perform standards compliance audits on study-level builds.


• Drive Metadata Repository (MDR) implementation (CRF to SDTM mapping).


• Author/maintain SOPs and Work Instructions for data collection standards and external integration.


• Ensure Trial Master File (TMF) is inspection-ready for data collection documentation.

Required Qualifications:

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


• 8+ years Clinical Data Management; 5+ years in Data Standards and EDC Database Design.


• Advanced experience with Medidata Rave (Architect/Global Library) or Veeva CDB/Vault EDC.


• Proven experience managing complex external data integrations.


• Expert knowledge of CDASH and strong working knowledge of SDTM.


• Familiarity with ICH-GCP, FDA, EMA.


• Experience in small-to-mid-size biotech; ability to pivot strategy to execution.


• Excellent attention to detail and analytical skills.


• Master’s degree or certification (e.g., CCDM, SAS Base Programmer).

Preferred Qualifications:

• MDR implementation experience; DHT data standards exposure.


• Proficiency in SAS/SQL or other data analysis tools (profiling/quality oversight).


• Experience with global trials and working with CROs/vendors.

US Salary Range: $121,500–$202,500