Associate Director, Clinical Data Management - Onsite

BioSpace; Weston (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

ModeX Therapeutics, an OPKO Health company, is seeking an Associate Director of Clinical Data Management to lead data management activities across programs. The role emphasizes data integrity, regulatory standards, and process improvements within a clinical operations team.

The candidate will oversee timelines, DM plans, CRF design, database build and testing, data review, and coordination with CROs to achieve database lock and go-live milestones.

Qualifications

• BA/BS degree required.
• 7-10+ years of experience in clinical research, drug development, or healthcare environments, including 5+ years in data management.
• Proven oncology data management experience with emphasis on quality and cross-functional environments.
• Strong teamwork and communication, organizational and interpersonal skills.

Responsibilities

• Lead data management from study start-up through final database lock for multiple programs.
• Create and track timelines for data management activities and develop DM plans.
• Develop CRFs and database build specifications; lead testing and edit checks.
• Review data, handle queries, and reconcile data from multiple sources (safety databases, labs).
• Coordinate CRO staff, ensure proper study documentation in trial master files, and drive DM milestones.

Skills

Teamwork

Communication

Organizational skills

Interpersonal skills

Leadership

Education

BA/BS degree

Job description

ModeX Therapeutics, an OPKO Health company, is seeking an Associate Director of Clinical Data Management to lead data management activities across programs. The role emphasizes data integrity, regulatory standards, and process improvements within a clinical operations team.

The candidate will oversee timelines, DM plans, CRF design, database build and testing, data review, and coordination with CROs to achieve database lock and go-live milestones.