Strategic Leader, Clinical Data Management

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

Job summary

Kiniksa Pharmaceuticals is seeking an Associate Director, Clinical Data Management to lead data management across clinical studies from protocol review through database lock, ensuring high-quality, analysis-ready data. This role is based in Lexington, MA and requires onsite presence five days per week.

You will oversee CRO data management activities, lead EDC database specification, and support regulatory submissions with robust data processes, SDTM/CDASH standards, and quality control

Qualifications

• Requires a Bachelor’s degree or higher (MS preferred) in a relevant scientific field with 6+ years in clinical data management.
• Proficient in data collection, cleaning and analysis for Phase I-IV trials in pharma/biotech.
• Experience with outsourced data management models and regulatory standards (GCP, ICH, FDA).

Responsibilities

• Lead data management activities for clinical studies and oversee CRO data management.
• Review protocols and study strategies to ensure compliant data collection.
• Coordinate with DB vendors and lead UAT for eCRF build and validation documents.
• Ensure high-quality data for lock, interim reviews, and final database lock.

Skills

Strategic thinking

Strong communication

Analytical skills

Leadership

Education

Bachelor’s degree or higher (MS preferred)

Tools

Medidata

Clinical Data Studio

CDASH/SDTM

Job description

Kiniksa Pharmaceuticals is seeking an Associate Director, Clinical Data Management to lead data management across clinical studies from protocol review through database lock, ensuring high-quality, analysis-ready data. This role is based in Lexington, MA and requires onsite presence five days per week.

You will oversee CRO data management activities, lead EDC database specification, and support regulatory submissions with robust data processes, SDTM/CDASH standards, and quality control