Associate Director, Clinical Data Management (Onsite 3–4 Days)

BioSpace; Weston (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

ModeX Therapeutics, based in Weston, Massachusetts, seeks an Associate Director of Clinical Data Management to lead data management activities across multiple programs with a focus on oncology. You will drive data integrity, planning, CRF design, database builds, and QA in a regulatory environment.

The role requires 7-10+ years in clinical research with 5+ years in data management, excellent teamwork and leadership skills, and onsite collaboration. Onsite 3–4 days per week is expected.

Qualifications

• 7-10+ years of experience in clinical research, drug development, or other healthcare environment.
• 5+ years of experience in data management.
• Proven track record of oncology data management excellence with focus on quality and matrix team environments.

Responsibilities

• Lead all data management activities from study start-up through final database lock for multiple programs.
• Create and track timelines for Data Management activities.
• Create and maintain the Data Management Plan.
• Develop and design Case Report Forms (CRFs).
• Develop Database Build specifications.
• Lead and execute Database Build and testing activities.
• Define, build, and test edit checks.
• Perform data review and query generation/resolution.
• Process/reconcile electronic data received from other data sources, Safety database, labs, etc.
• Database lock and transfer process.
• Track project progress and issue status reports to ensure the achievement of key Data Management milestones, such as database Go-Live and completion of tasks towards Database Lock.
• Coordinate the work of CRO staff assigned to the project.
• Ensure approved study documentation is maintained and properly stored in the trial master files
• Develop or assist with the project training development and delivery, for investigators, clinical sites, project teams and CRO on data collection processes, tools and/or equipment as required
• Act as point of escalation for data related issues and queries
• Contribute to the continuous improvement of DM and the wider organization through information sharing, training and education
• May lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM
• May participate in and/or lead DM and cross functional working groups

Skills

Leadership / mentoring

Teamwork

Communication

Prioritization

Education

BA/BS degree

Job description

ModeX Therapeutics, based in Weston, Massachusetts, seeks an Associate Director of Clinical Data Management to lead data management activities across multiple programs with a focus on oncology. You will drive data integrity, planning, CRF design, database builds, and QA in a regulatory environment.

The role requires 7-10+ years in clinical research with 5+ years in data management, excellent teamwork and leadership skills, and onsite collaboration. Onsite 3–4 days per week is expected.