Director, Data Management

Scorpion Therapeutics; United States; Hybrid; USD 205,000 - 230,000; Full time

Benefits offered by this job

Hybrid work arrangement

Performance bonus

Comprehensive benefits

Job summary

Scorpion Therapeutics in Waltham, MA seeks an experienced Data Management leader to steer global clinical data programs with strategic vision. You will partner across disciplines, govern CROs, and drive quality datasets from DB design through lock, while mentoring a growing team.

Hybrid work model with on-site presence required; base salary $205,000–$230,000, plus annual performance bonus and comprehensive benefits.

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Computer Science or related field.
• 10+ years data management in pharma/biotech with at least 3 years supervisory/leadership.
• Lead Data Manager with end-to-end experience across multiple studies.
• Experience with global trials and geographically distributed teams.
• Advanced GCP/ICH knowledge and 21 CFR Part 11.
• Strong leadership, cross-functional collaboration, and multitasking skills.

Responsibilities

• Provide strategic and operational leadership for Clinical Data Management across all programs.
• Plan, coordinate, and oversee Data Management deliverables for studies.
• Oversee CROs and external Data Management vendors.
• Establish vendor KPIs, quality metrics, timelines, and governance meetings.
• Oversee end-to-end database design, validation, testing, deployment, and maintenance.
• Develop study-level Data Management strategies and data collection approaches.
• Ensure inspection readiness of TMF documentation and deliverables.
• Establish standards for eCRF design, CDASH, and CDISC outputs.
• Collaborate with Biostatistics/Statistical Programming on datasets.
• Develop department performance metrics; lead SOPs, systems, governance initiatives.
• Evaluate new technologies and RBQM/ centralized monitoring as applicable.
• Recruit, mentor, and manage Data Management staff.

Skills

Data management leadership

Data Management

GCP/ICH knowledge

21 CFR Part 11

Cross-functional collaboration

Regulatory knowledge

Team leadership

Global trials experience

SAS

Education

Bachelor’s degree in Life Sciences/Health Sciences/Computer Science/Clinical Research or related

Tools

SAS

CDISC (CDASH, SDTM)

Job description

Responsibilities

• Provide strategic and operational leadership for Clinical Data Management across all clinical development programs.
• Plan, coordinate, and oversee Data Management deliverables for internally managed studies.
• Provide sponsor oversight for CRO-managed studies and govern external Data Management vendors.
• Establish and monitor vendor performance via KPIs, quality metrics, timelines, issue management, and governance meetings.
• Oversee end-to-end clinical trial database design, build, validation, testing, deployment, and maintenance (ICH-GCP, regulatory, company standards).
• Develop study-level Data Management strategies (data collection approaches, risk-based data cleaning, database quality objectives).
• Ensure inspection readiness of Clinical Data Management Trial Master File (TMF) documentation and deliverables.
• Establish standards for eCRF design, CDASH, controlled terminology, data collection conventions, and CDISC-compliant outputs.
• Oversee key documentation (DMPs, DVS, edit checks, manual data review, data review plans, database lock).
• Partner with Biostatistics/Statistical Programming to deliver quality datasets (cleaning, queries, SAS listing review, TLF dry runs, lock).
• Develop and communicate departmental performance metrics; lead initiatives (SOPs, standards, systems, optimization, automation, data integration, governance).
• Evaluate new technologies/best practices; support RBQM/centralized monitoring as applicable.
• Recruit, mentor, and manage Data Management staff; represent Data Management on cross-functional governance committees.

Qualifications

• Bachelor’s degree (Life Sciences/Health Sciences/Computer Science/Clinical Research or related).
• 10+ years data management in pharma/biotech (at least 3 years supervisory/leadership); CCDM preferred.
• Lead Data Manager (or equivalent) with end-to-end experience across multiple studies.
• Experience with global trials and geographically distributed teams.
• Advanced GCP/ICH knowledge and 21 CFR Part 11.
• Strong leadership, cross-functional collaboration, and organizational/interpersonal/multi-tasking skills.

Hybrid/Compensation

• Hybrid: ~60% office / 40% home; onsite at Waltham, MA at least 3 days/week; not fully remote.
• Base salary: $205,000–$230,000; eligible for annual performance bonus; competitive benefits package.