Associate Director, Data Management

Scorpion Therapeutics; Boston (MA); Hybrid; USD 160,000 - 230,000; Full time

Job summary

Scorpion Therapeutics is seeking an experienced Senior Clinical Data Manager to lead and oversee all data management activities across assigned trials, from protocol development through database lock and study closeout.

You will design and execute data management strategies that support timelines, quality objectives, and regulatory submission readiness, while ensuring compliance with GCP, ICH guidelines, and company SOPs. Collaboration with CROs and cross-functional teams is essential.

Qualifications

• 8+ years in clinical data management in biotech/pharma/CRO.
• Leadership experience overseeing data management and vendors.
• Experience across Phase 2/3 and regulatory submissions.
• Experience with outsourced data management models.

Responsibilities

• Lead and oversee all clinical data management activities from protocol through database lock and closeout.
• Develop data management strategies aligned with program timelines and regulatory readiness.
• Ensure adherence to GCP, ICH, SOPs and industry standards.
• Provide leadership to CROs and vendors; establish governance and KPIs.

Skills

Data management leadership

Vendor management

Data quality

Risk management

Communication

Strategic thinking

GCP ICH knowledge

Tools

CDISC SDTM

Job description

Responsibilities

• Lead and oversee all clinical data management activities for assigned clinical trials from protocol development through database lock and study closeout.
• Develop and execute data management strategies supporting program timelines, quality objectives, and regulatory submission readiness.
• Ensure consistent application of GCP, ICH guidelines, company SOPs, and industry best practices.
• Provide leadership and guidance to CROs and vendors performing outsourced data management.
• Serve as primary sponsor representative for outsourced data management; establish governance and performance oversight (KPIs, quality metrics, issue escalation).
• Review and approve vendor deliverables (Data Management Plans, CRF specifications, Edit Check Specifications, Data Review Plans, Database Validation Documentation, Data Transfer Specifications, Reconciliation Plans).
• Monitor CRO performance for quality, timelines, and budget adherence.
• Establish and monitor key study metrics for data quality, cleaning, query management, and database readiness; lead review of data trends and risk mitigation.
• Ensure audit and inspection readiness; support internal audits and health authority inspections as data management SME.
• Collaborate cross-functionally (Clinical Operations, Biostatistics, Statistical Programming, Medical Writing, Pharmacovigilance, Regulatory Affairs).
• Identify process improvement opportunities; contribute to SOPs/templates; support risk-based approaches and innovative technologies.

Requirements

• 8+ years clinical data management experience in biotech/pharma/CRO.
• 3+ years leadership overseeing clinical data management and vendor relationships.
• Experience supporting Phase 2/3 and regulatory submission programs.
• Experience overseeing outsourced clinical data management models.
• Strategic thinker with strong operational execution; excellent vendor management.
• Problem-solving and risk management; excellent written/verbal communication.
• Commitment to patient-focused drug development and data quality excellence.
• Rare disease experience preferred.

Strong understanding of

• ICH-GCP; FDA/EMA regulations; CDISC (SDTM); clinical trial data lifecycle; risk-based quality management.

Location/Work model

Boston, MA; flexible hybrid work model (minimum 2 days/week in office).