CDM Manager

Scorpion Therapeutics; United States; On-site; USD 140,000 - 220,000; Full time

Job summary

Scorpion Therapeutics is seeking a Clinical Data Management (CDM) lead to oversee CDM execution at the project level for products or complex studies, including CRF/eCRF design, review of protocols, and vendor coordination.

You will mentor CROs and study teams on CDM requirements, support regulatory submissions, ensure data completeness and regulatory compliance, and drive CDM process improvements with vendors.

Qualifications

• PhD in life sciences/related; or MA/MS with 4+ years; BA/BS with 6+ years in CDM or data analytics/data management. Prefer PhD + 2+ years CDM/data management.
• Experience leading small projects/teams.

Responsibilities

• Act as CDM lead; oversee CDM execution at the project level (products or complex studies).
• Lead CRF/eCRF design; review study protocols and plan/implement CDM portions of clinical studies.
• Oversee vendors for data review, transfers and reporting; use routine/non-routine reports to track progress and meet timelines/quality.
• Guide/training for CROs, vendors, investigators and study coordinators on CDM requirements.
• Support regulatory submissions; assist with CDM questions for audits/inspections; lead special projects as needed.
• Oversee CDM process design/implementation with vendors (entry, QC, transfer, reporting, backup/recovery).
• Ensure data completeness/accuracy/consistency and adherence to CDM system processes for regulatory compliance.

Skills

CDM leadership

Regulatory knowledge

Project management

Mentoring

Communication

Education

PhD in life sciences/related

MA/MS with 4+ years in CDM

BA/BS with 6+ years in CDM

Job description

Clinical Data Management (CDM) supports drug discovery, development and marketed products by ensuring accurate and timely acquisition, analysis and reporting of clinical data through CRF/eCRF design, editing specifications, and query resolution. CDM also manages data transfers from vendors (e.g., central labs).

Responsibilities

• Act as CDM lead; oversee CDM execution at the project level (products or complex studies).
• Lead CRF/eCRF design; review study protocols and plan/implement CDM portions of clinical studies.
• Oversee vendors for data review, transfers and reporting; use routine/non-routine reports to track progress and meet timelines/quality.
• Guide/training for CROs, vendors, investigators and study coordinators on CDM requirements.
• Support regulatory submissions; assist with CDM questions for audits/inspections; lead special projects as needed.
• Oversee CDM process design/implementation with vendors (entry, QC, transfer, reporting, backup/recovery).
• Ensure data completeness/accuracy/consistency and adherence to CDM system processes for regulatory compliance.

Requirements (Minimum Education & Experience)

• PhD in life sciences/related; or MA/MS with 4+ years; BA/BS with 6+ years in relevant CDM or data analytics/data management. Prefer PhD + 2+ years CDM/data management.
• Experience leading small projects/teams.

Knowledge & Other Requirements

• Demonstrated leadership of CDM deliverables; knowledge of FDA/EMA regulations and NDA; strong project/risk management and communication.
• Ability to mentor, delegate, and adapt; travel when needed.

People Leader Accountabilities

• Create Inclusion
• Develop Talent
• Empower Teams

Benefits (if eligible)

• company-sponsored medical, dental, vision, life insurance; may include bonus/stock-based long-term incentives and paid time off.