Associate Director, Data Manager

Scorpion Therapeutics; Cambridge (MA); On-site; USD 140,000 - 200,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director of Clinical Data Management to lead global data activities across early- and late-phase trials in genetic medicine. You will oversee end-to-end data management, from study start-up through database lock, and ensure regulatory compliance (GxP, 21 CFR Part 11, ICH, GCDMP).

You will collaborate with Clinical Development, Biostatistics, Regulatory, and Operations to maintain data quality, integrity, and audit readiness for regulatory submissions.

Qualifications

• 8+ years in clinical data management and CRO oversight.
• Experience with Phase I–IV outsourced trials.
• Strong communication and leadership in a fast-paced environment.

Responsibilities

• Oversee end-to-end data management from start-up to database lock.
• Collaborate with Clinical Development, Biostatistics, Regulatory, and Operations to ensure data quality and audit readiness.
• Manage data system configurations, transfer protocols, validation activities, and data quality metrics.

Skills

Cross-functional leadership

Regulatory compliance

Data quality management

Education

Bachelor's in Life Sciences

Tools

Medidata Rave

CDISC standards

RBM

Job description

Role: Associate Director, Clinical Data Management, leading data activities for global early- and late-phase clinical trials in biopharma, with a focus on genetic medicines utilizing RNA editing platforms.

Responsibilities

• Oversee end-to-end data management from study start-up to database lock, including CRO/vendor oversight, database design, data cleaning, and ensuring regulatory compliance (GxP, 21 CFR Part 11, ICH, GCDMP).
• Collaborate with cross-functional teams (Clinical Development, Biostatistics, Regulatory, Operations) to ensure data quality, integrity, and audit readiness, contributing to regulatory submissions.
• Manage data system configurations, transfer protocols, and validation activities, with a strong emphasis on data quality, metrics, and inspection preparedness.

Qualifications

• Bachelor's in Life Sciences or related field;
• 8+ years in clinical data management, with experience managing CRO relationships and overseeing outsourced activities in Phase I-IV trials.
• Technical expertise in EDC platforms (e.g., Medidata Rave), data standards (CDISC), and familiarity with advanced data analytics, RBM, and AI-enabled tools.
• Strong communication, risk mitigation, and leadership skills in a fast-paced, innovative environment.

High-Value

Experience with complex, regulated clinical trials in genetic or nucleic acid-based therapeutics, with an emphasis on data quality, regulatory compliance, and cross-functional collaboration.