Associate Director, Clinical Data Management

ModeX Therapeutics Inc; Weston (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

A biopharmaceutical company based in Weston, MA, is looking for an Associate Director of Clinical Data Management. This role involves leading all data management activities, ensuring data integrity, and collaborating with multiple teams to achieve strategic goals. Candidates should have a BA/BS degree and 7-10 years of experience in clinical research, with a strong focus on oncology data management. This position is ideal for self-motivated individuals with excellent communication and organizational skills.

Qualifications

• 7-10+ years of experience in clinical research, drug development, or a healthcare environment.
• 5+ years of experience in data management.
• Proven track record of oncology data management excellence.

Responsibilities

• Lead all data management activities from study start-up through final database lock.
• Create and maintain the Data Management Plan.
• Develop and design Case Report Forms (CRFs).
• Coordinate work of CRO staff assigned to the project.

Skills

Clinical research

Data management

Teamwork

Communication skills

Organizational skills

Leadership

Education

BA/BS degree

Job description

Job Summary

The Associate Director of Clinical Data Management is a critical position within the ModeX clinical operations team. This position is responsible for successfully leading the execution of all data management activities, ensuring focus on data integrity, validity, reliability in accordance with standard processes, guidelines, industry best practices and regulatory standards. This position may be involved in process improvement initiatives to support the department and company in achieving objectives and strategic goals.

Key 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

Qualifications

• BA/BS degree required
• 7-10+ years of experience in clinical research, drug development, or other healthcare environment, including 5+ years of experience in data management
• Proven track record of oncology data management excellence with a focus on quality and matrix team environments
• Excellent teamwork, communication (verbal and written), organizational, and interpersonal skills
• Self-motivated, proactive, and able to prioritize and manage multiple initiatives simultaneously
• Leadership / mentoring experience is a plus

ModeX Therapeutics is an Equal Opportunity Employer