Director, Clinical Data Management

Scorpion Therapeutics; United States; On-site; USD 170,000 - 230,000; Full time

Benefits offered by this job

Equity plans

Health insurance

401(k) with matching

Unlimited vacation & sick days

Job summary

Scorpion Therapeutics is hiring a Director of Clinical Data Management to lead data management for oncology trials. You will own data strategy, CRF design, and DM metrics, coordinating with operations, statistics, medical, and regulatory teams to ensure timely, quality deliverables across studies.

The role requires 8+ years in clinical data management, strong leadership, and deep knowledge of CDISC standards and regulatory guidelines.

Qualifications

• Bachelor’s degree required in life sciences, data science, or related field.
• 8+ years of clinical data management experience in biotech/pharma/CRO.
• 3+ years managing people, vendors, and cross-functional teams.
• Regulatory knowledge of GCP/ICH guidelines and NDA/BLA submissions.

Responsibilities

• Serve as primary data management lead for oncology trials and ensure high-quality deliverables.
• Develop and maintain DMPs, CRF completion guidelines, edit check specs, and data transfer specs.
• Oversee CRF design, eCRF programming, and database setup with CROs and stakeholders.
• Coordinate data review, query management, data cleaning, and database lock support.
• Lead DM-related tools and process improvements; support audits/inspections.

Skills

Leadership

CDISC SDTM/CDASH

Medidata Rave

GCP/ICH

Vendor management

Oncology data

Regulatory submissions

Education

Bachelor’s degree in life sciences or related

Advanced degree preferred

Tools

None specified

Job description

Director of Clinical Data Management (CDM)

Responsibilities

• Serve as primary data management lead for assigned oncology clinical trials; ensure timely, high-quality deliverables.
• Develop and maintain study data management plans (DMPs), CRF completion guidelines, edit check specifications, and data transfer specifications.
• Oversee CRF design, eCRF programming, and database setup with CRO partners/internal stakeholders.
• Coordinate data review, query management, and data cleaning; support interim/final database lock.
• Ensure compliance with regulatory requirements (ICH GCP, FDA) and industry best practices (e.g., GCDMP).
• Integrate and reconcile external data sources (central labs, imaging, biomarkers, other third-party providers).
• Partner with Clinical Operations, Biostatistics, Medical, and Regulatory Affairs; act as data management point-of-contact through planning, conduct, and closeout.
• Lead Data Working Groups and cross-functional data review meetings.
• Contribute to protocol and SAP development from a data management perspective.
• Provide oversight of ex-US DM collaborators, CROs, and vendors; participate in selection/contracting and define vendor performance metrics.
• Support SOP/process improvements; support audits/inspections; lead/participate in data-focused initiatives (e.g., new review tools, R Shiny apps, workflow standardization, ePRO/wearables).
• As team grows, may mentor/line-manage junior CDM staff/contractors and support onboarding/training.

Qualifications & Skills

• Bachelor’s degree required (life sciences, data science/statistics/math, computer science, health informatics, or related); advanced degree preferred.
• 8+ years clinical data management experience (biotech/pharma/CRO).
• 3+ years managing people, vendors, and functional teams.
• Leadership, strategic thinking, communication.
• Clinical data systems knowledge (preferably Medidata Rave) and CDISC standards (SDTM, CDASH).
• Vendor management/outsourced data management experience.
• Thorough understanding of GCP/ICH/regulatory guidelines.
• Fast-paced, hands‑on mindset; startup/small biotech experience desirable.
• Oncology familiarity with complex data types (imaging, genomics, digital endpoints) desirable.
• Regulatory submission experience (NDA/BLA) is a plus.

Benefits

• Competitive base salary, bonus, and equity plans; unlimited vacation and 10 sick days annually; medical/dental/vision; 401(k) with matching.

No application instructions provided.