Principal Data Manager

Scorpion Therapeutics; United States; Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Premium health

Life insurance

Disability coverage

Retirement match

Generous paid time off

Job summary

Scorpion Therapeutics is seeking a Principal Data Manager to oversee start-up and execution of clinical trials with CROs or in-house teams, ensuring data quality and regulatory-compliant data for submissions and publications.

You will lead CDM oversight, manage data platform integrations, review deviations, and drive solutions while maintaining timelines and budgets. Expect ~10% travel and onsite collaboration in San Diego as needed.

Qualifications

• Knowledge of drug development and clinical data management.
• Clinical trials design using CDASH/SDTM terminology; ICH/GCP knowledge.

Responsibilities

• Single point of accountability for data management deliverables within a clinical development program.
• Lead CDM oversight of CROs/third-party vendors for data management to completion.
• Lead internal data management deliverables.
• Manage data platform system integrations; archival and filing in Trial Master Plan.
• Perform ongoing data review to identify discrepancies/trends and drive resolutions.
• Review protocol deviations, dictionary coding, and UAT.
• Create data management process documents (plans, specs, workflows).
• Lead cross-functional meetings; strategize database locks for multi-study deliverables.
• Provide SOP/protocol input from a data management perspective.
• Use AI models to increase productivity; guide CDM personnel.
• Set up, maintain, and archive project documentation; monitor activity; ensure inspections.

Skills

Data management leadership

CDASH/SDTM

ICH/GCP knowledge

EDC systems

Medidata RAVE

CRO/vendor oversight

Data integrations (EDC, IRT, ePRO)

Dictionary coding (MedDRA, WHODrug)

Project/time management

Travel ~10%

Tools

Medidata RAVE

Job description

Position Summary:

Principal Data Manager overseeing start-up and execution of clinical trials with CROs or in-house teams to ensure data quality, integrity, and regulatory-compliant data supporting publications and regulatory submissions.

Responsibilities:

• Single point of accountability for data management deliverables within a clinical development program.
• Lead CDM oversight of CROs/third-party vendors for data management to completion.
• Lead internal data management deliverables.
• Manage data platform system integrations; ensure review outputs are filed as appropriate in Trial Master Plan.
• Perform ongoing data review to identify discrepancies/trends and drive resolutions.
• Review protocol deviations, dictionary coding, and conduct database user acceptance testing.
• Review vendor and internal documents.
• Create data management process documents (plans, specifications, agreements, workflows, timelines, communications).
• Lead cross-functional meetings; strategize database locks and multi-study deliverables for consistency.
• Provide SOP/protocol input from a data management perspective.
• Use AI models to increase productivity; guide CDM personnel.
• Set up, maintain, and archive project documentation; monitor own activities/status; adhere to budgets/timelines; ensure inspection readiness.

Qualifications / Required & Preferred Skills:

• Knowledge of drug development and clinical data management; guidance experience.
• Clinical trials design using CDASH/SDTM terminology; ICH/GCP knowledge.
• Communication/interpersonal skills.
• EDC system experience; preferred Medidata RAVE.
• Outsourced study/CRO team management experience; data integrations (EDC, IRT, ePRO, lab processing/reconciliation).
• Dictionary coding (MedDRA, WHODrug); project/time management; accountability; travel ~10%; not 100% remote (San Diego onsite as needed).

Benefits:

• Premium health and work-life/well-being offerings; life insurance/disability; retirement match; generous paid time off.