Strategic Leader, Clinical Data Management

Kiniksa Pharmaceuticals; Lexington (MA); On-site; USD 198,000 - 210,000; Full time

Job summary

Kiniksa Pharmaceuticals, a commercial‑stage biopharmaceutical company, is seeking an Associate Director, Clinical Data Management. Based in Lexington, MA, this role leads end‑to‑end data management for clinical studies, from protocol review through database lock and regulatory support, ensuring high‑quality analysis‑ready data.

You will oversee CRO data activities, define data collection standards (EDC, SDTM), prepare for submissions, and drive timelines while managing cross‑functional teams in

Qualifications

• Bachelor’s degree or higher in a relevant scientific field; MS preferred.
• 6+ years of clinical data management experience in pharma/biotech.
• Experience in Phase I–IV trials and outsourced data management models.
• Knowledge of EDC, CDASH/SDTM, medical terminology and coding dictionaries.
• Familiarity with GCP, ICH and FDA requirements.
• Prior experience filing a BLA or NDA is preferred.
• Ability to manage multiple initiatives and shifting priorities in a small company.
• Excellent interpersonal and collaborative skills.

Responsibilities

• Oversee data management activities for clinical studies and CRO data management support.
• Review protocols and strategies to ensure feasible, compliant data collection.
• Lead cross-functional data reviews and align stakeholders on quality, timelines and risks.
• Develop SOPs and working practice documents for data management tasks.
• Drive study milestones and proactively identify risks with solutions.
• Review/Develop data specifications and data transfer agreements.
• Coordinate with vendors and oversee UAT for eCRF build and validation.

Skills

Clinical data management

EDC systems

GCP/ICH

Project leadership

Cross-functional collaboration

Education

Bachelor’s or higher in a relevant scientific field

MS preferred

Tools

Medidata

Clinical Data Studio

Job description

Kiniksa Pharmaceuticals, a commercial‑stage biopharmaceutical company, is seeking an Associate Director, Clinical Data Management. Based in Lexington, MA, this role leads end‑to‑end data management for clinical studies, from protocol review through database lock and regulatory support, ensuring high‑quality analysis‑ready data.

You will oversee CRO data activities, define data collection standards (EDC, SDTM), prepare for submissions, and drive timelines while managing cross‑functional teams in