Principal Specialist, Clinical Data Management

Scorpion Therapeutics; San Diego (CA); On-site; USD 131,000 - 179,000; Full time

Benefits offered by this job

Health benefits

Bonus program

Equity compensation

Retirement match

Paid time off

Job summary

Scorpion Therapeutics invites an experienced data management leader to oversee data activities across clinical studies and programs. You will design eCRFs, coordinate user acceptance testing, and ensure high-quality data for regulatory submissions.

The role requires strong supervisory experience, deep knowledge of CDISC/SDTM standards, and proficiency with Medidata Rave. Collaboration with Medical, Regulatory, and QA teams is essential.

Qualifications

• BS/BA in computer science or related field with 8+ years pharma experience.
• 3+ years supervisory/lead experience.
• Proficiency with Medidata Rave.
• Knowledge of CDISC/SDTM and FDA guidelines.

Responsibilities

• Leads, performs, and oversees data management activities for clinical studies and/or clinical programs.
• Performs hands-on clinical data management tasks: reviewing protocols, designing eCRFs, coordinating UAT, documenting edit check specs, QC’ing external data transfers, data quality checks/discrepancy review, and ensuring database lock activities.
• Develops policies, SOPs, processes, and documents for data management.
• Provides technical expertise and training within Data Management and related teams.

Skills

Data management

Leadership

Project management

Analytical

Communication

Education

BS/BA in computer science or related

MS in related field

PhD

Tools

Medidata Rave

SAS

Business Objects

Job description

About The Role

Leads, performs, and oversees data management activities for assigned clinical studies for both in-house and outsourced clinical trial data; evaluates, develops, and implements data management processes, procedures, and tools to ensure business requirements are met; collaborates with Medical, DSPV, Regulatory, QC, and other internal customers to ensure high quality data in support of regulatory submissions, safety reporting, and publications.

Your Contributions

• Leads, performs, and oversees data management activities for clinical studies and/or clinical programs
• Performs hands‑on clinical data management tasks: reviewing protocols, designing eCRFs, coordinating UAT, documenting edit check specs, QC’ing external data transfers, data quality checks/discrepancy review, and ensuring database lock activities
• Develops policies, SOPs, processes, and documents for data management
• Provides technical expertise and training within Data Management and related teams
• Supports QA audit responses and ensures Corrective Action Forms (CAFs) are closed appropriately
• Recommends improvements to data management practices and technology solutions
• Assists with standardized documents (eCRFs, edit checks)
• Oversees screening/selection/validation/implementation of data management software purchases/upgrades
• Participates in selecting outsourcing vendors; reviews proposal scope; monitors budgets as appropriate
• Coordinates timelines (database lock, DSMB, data review) and monitors CRO data management performance
• Ensures quality control checks and audit procedures are followed
• Runs data review listings; queries; codes Medical History and AE data using MedDRA; codes Concomitant Medications using WHO Drug
• Collaborates with database programmers to ensure CDISC/SDTM standards
• Identifies risks and communicates issues/solutions
• Participates in data management-related NDA submissions, as appropriate
• Supports performance evaluations and development plans

Requirements

• BS/BA in computer science (or related) + 8+ years pharma industry experience (in-house/sponsor or CRO); OR MS + 6+ years; OR PhD + 4+ years
• 3+ years supervisory/lead experience
• Knowledge of data management best practices; ability to work on and lead multiple teams
• Excellent computer skills; strong communication, problem-solving, analytical, and project management skills
• Proficiency with Word, Excel, PowerPoint; thorough understanding of drug development
• Proficiency with Medidata Rave (required)
• Strong knowledge of Good Clinical Data Management Practices; CDISC/CDASH/SDTM; FDA/industry guidelines (required)
• Familiarity with Business Objects and SAS helpful; other programming languages a plus

Benefits/Compensation

• Annual base salary: $130,800.00–$179,000.00; annual bonus (target 30% of earned base); equity long-term incentive; retirement match; paid vacation/holidays/personal days; caregiver/parental and medical leave; health benefits.