Sr. Manager, Clinical Data Management (Lead)

Scorpion Therapeutics; South San Francisco (CA); On-site; USD 155,000 - 202,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Scorpion Therapeutics in South San Francisco is seeking a Senior Clinical Data Manager Lead to guide data collection, standardization, and quality across complex programs. You will drive CDM deliverables, oversee CRO partnerships, and mentor junior staff while ensuring compliance with ICH/FDA, CDISC standards, and regulatory expectations.

This role requires strategic problem-solving, strong collaboration across functions, and the ability to manage timelines and risk in a fast-paced biotech

Qualifications

• Bachelor's degree required in mathematics, science, or health-related field.
• 10+ years of clinical data management experience in biotech/pharma/health.
• 3+ years coaching/oversight of data management teams.

Responsibilities

• Provide clinical data management leadership as primary point of contact for complex programs.
• Enforce data standards and regulatory compliance (ICH/FDA, CDISC CDASH/SDTM/ADaM).
• Lead/advise on SOP development, training, and process mapping in CDM.
• Oversee CROs for data management activities and budgets.

Skills

CDM leadership

Regulatory data standards

Cross-functional collaboration

Analytical/problem-solving

Independent work

Education

Bachelor's degree in mathematics, science, or health-related field

Job description

Key Accountabilities / Core Job Responsibilities:

• Provide clinical data management leadership as primary point of contact to align on and drive data collection requirements for one or more complex programs.
• Enforce data standard conventions and quality expectations; ensure compliance with applicable regulations and guidelines.
• Lead/support continuous improvement activities within CDM (SOP development, training, process mapping).
• Anticipate internal resource needs; partner with Head of CDM on contracting vs. FTE approaches.
• Review and approve key CDM deliverables (CRF design/completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specs, SAE reconciliation plans, medical coding, data listing specs, electronic data transfer agreements).
• Provide quality/project oversight over CROs for DM activities (review vendor proposals, budgets, scopes of work).
• Manage/oversee study setup, testing, and system validation for new studies with the DM vendor, including CRO-executed data cleaning.
• Develop/manage timelines for key CDM deliverables with the CDM CRO and project team.
• Communicate complex issues/solutions and escape to senior management as needed.
• Coach and provide quality oversight of junior Data Management Leads; assist with QA findings and Health Authority inspections/audits.

Qualifications/Skills:

• Bachelor's degree in mathematics, science, or health-related field; 10+ years clinical data management experience (biotech/pharma/health-related), including 3+ years coaching/oversight.
• CDM deliverable leadership across Phase 1-4 trials (including early-phase/dose-escalation).
• Knowledge of clinical drug development process and regulatory/data standards (ICH/FDA, CDISC CDASH/SDTM/ADaM, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, GDPR).
• Understanding of clinical trial database lifecycle (CRF design, development/testing, discrepancy management, data quality review, database lock).
• Proactive risk identification and strategic solutioning; strong interpersonal and communication skills.
• Strong analytical/problem-solving skills; ability to work independently and cross-functionally.

Benefits/Compensation:

• Salary range: $155,000.00 to $202,000.00.
• Competitive total rewards package including 401k, healthcare coverage, ESPP and other benefits.