Senior Manager, Clinical Data Management

Scorpion Therapeutics; Burlington (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior Lead Data Manager to drive day‑to‑day clinical data management across MBX programs. You will oversee EDC/eCOA design, specs reviews, and UAT, ensuring high‑quality, audit‑ready databases and documents.

You will develop DM plans, lead data review meetings, and coordinate data transfers with CROs and vendors. The role requires strong cross‑functional collaboration, regulatory knowing, and a track record in global Phase 2/3 studies.

Qualifications

• Master’s in Life/Health Sciences, Data Management, Computer Science, or related field (advanced degree preferred).
• 9+ years in Clinical Data Management with global Phase 2/3 experience as Lead Data Manager.
• Hands‑on experience with Medidata Rave EDC: design, development, UAT, modifications, and lock.
• Experience with eCOA/eDiary systems and vendor management.
• Experience with multi‑source data and TMF/ICH‑GCP regulatory expectations.

Responsibilities

• Lead day‑to‑day clinical data management operations across MBX programs.
• Oversee EDC and eDiary/eCOA design, development, and database modifications; review specs.
• Perform UAT, validation activities, and documentation for compliant databases.
• Develop and maintain Data Management Plans and CRF Completion Guidelines.
• Lead data review meetings and deliver data listings to clinical/medical teams.
• Conduct proactive data surveillance and data quality checks for endpoints.
• Oversee CRO data management teams and external data vendors; manage DTAs and data transfers.
• Coordinate integration/reconciliation of external data sources (IRT, labs, imaging).
• Plan database interim/final locks; manage timelines and risks with Biostatistics.
• Oversee TMF data management QC and inspection readiness.

Skills

Leadership

Cross-functional communication

Project coordination

Data governance

Quality assurance

Education

Master’s degree

Tools

Medidata Rave

Job description

What You’ll Do

• Lead day-to-day clinical data management operations across MBX programs.
• Oversee EDC and eDiary/eCOA design/development and database modifications, including specifications review/approval.
• Oversee and perform UAT, validation activities, and documentation for compliant, high-quality databases.
• Develop, maintain, and update Data Management Plans (DMPs), CRF Completion Guidelines (CCGs), and related DM documentation.
• Lead data review meetings and deliver data listings to clinical and medical teams.
• Perform proactive data surveillance and critical data reviews/reconciliations for completeness, quality, and timely primary/key secondary endpoint data.
• Oversee CRO data management teams and external data vendors; manage Data Transfer Agreements and ensure timely (and quality) data transfers.
• Oversee integration/reconciliation of external data sources (IRT, eCOA/eDiary, labs, imaging, safety).
• Plan and execute database interim/final locks; manage timelines, risks, and on-time delivery to Biostatistics.
• Oversee final subject data profile format review/deliveries; ensure TMF data management documentation QC and inspection readiness.

What You’ll Bring

• Master’s in Life/Health Sciences, Data Management, Computer Science, or related field (advanced degree preferred).
• 9+ years in Clinical Data Management (biotech/pharma/CRO), including Lead Data Manager on global Phase 2/3 studies.
• Hands‑on experience with Medidata Rave (or equivalent) EDC: design, database development, specifications review, UAT, modifications, lock.
• Experience with eCOA/eDiary systems, including design/specification review, UAT, modifications, and vendor management.
• Experience with multi‑source data (central lab, IRT, specialty labs, etc.).
• Strong knowledge of ICH‑GCP, regulatory requirements, inspection readiness, and TMF expectations.
• Proven ability to oversee vendors/CROs and manage DM deliverables across studies; strong cross‑functional communication and problem‑solving.