Associate Director, Clinical Data Management

Scorpion Therapeutics; Princeton (NJ); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health coverage

Paid time off

401(k)

Job summary

Scorpion Therapeutics is seeking an Associate Director, Clinical Data Management in New Jersey to lead data management for complex clinical development programs and ensure timely, high-quality trial data.

The role requires 7+ years in Biopharma/CRO, 3+ years in study leadership, a life sciences/data science/statistics degree, Medidata RAVE experience, strong PM and communication skills; travel 5–10%.

Qualifications

• Bachelor's degree in life sciences/data science/statistics required; advanced degree preferred.
• 7+ years Biopharma/CRO experience; 3+ years in study/program leadership.
• Travel: 5–10%.

Responsibilities

• Provide clinical data management leadership for complex development projects.
• Plan, coordinate, and deliver complete, high-quality trial data on time.
• Lead end-to-end data management; be primary DM contact for study teams.
• Set program-level data collection and review standards with cross-functional teams.
• Oversee third-party vendors for data management deliverables.
• Collaborate on EDC and related data collection systems; enforce data standards.
• Author/review DM study plans and data documentation.
• Chair Data Quality Review meetings to ensure data currency and completeness.
• Represent DM on cross-functional teams; support inspections and CAPA.
• Coach junior DM leads; participate in department DM Lead forums.

Skills

Clinical drug development process

FDA/ICH data management

Project management

Metrics analysis/reporting

Communication skills

NDA/BLA/MAA knowledge

MS Office proficiency

Education

Bachelor's degree in life sciences/data science/statistics

Advanced degree preferred

Tools

Medidata RAVE

Job description

Position Summary

Associate Director, Clinical Data Management

Key Responsibilities

• Provide clinical data management leadership for complex clinical development projects; align on and drive data collection requirements.
• Plan, coordinate, and deliver complete, high-quality, reliable clinical trial data on time.
• Lead end-to-end clinical data management; primary point of contact for internal/external study teams.
• Set program-level data collection/review standards with cross-functional teams and global standards.
• Oversee third-party vendors for data management deliverables; manage data currency.
• Collaborate on EDC and related data collection systems (eCOA, External Data, Safety Gateway); enforce data standards and quality expectations.
• Author/review DM study plans and documents (e.g., Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines).
• Chair Data Quality Review meetings to ensure data currency, quality, and completeness.
• Represent DM on cross-functional project and submission teams; lead/support Health Authority inspections, audits, and CAPA.
• Coach junior Data Management Leads; lead/co-chair department Data Management Lead forums.

Qualifications & Experience

• Bachelor’s degree in life sciences/data science/statistics (advanced degree preferred).
• 7+ years Biopharma/CRO experience; 3+ years in study/program leadership.
• Travel: 5–10%.

Required/Preferred Skills

• Clinical drug development process knowledge; FDA/ICH and data management best practices.
• EDC systems expertise (Medidata RAVE preferred); strong MS Office skills.
• Strong project management, metrics analysis/reporting; excellent oral/written communication.
• Knowledge of submission requirements (e.g., NDA/BLA/MAA).

Benefits (as listed)

• Health coverage; wellbeing support; financial wellbeing/protection (401(k), disability, life/accident, insurance, legal support).
• Paid time off options (flexible time off and/or vacation per employee type) and other eligibility-based leaves.