Company Description

ClinFocus specializes in empowering life sciences organizations by providing advanced technology-driven solutions and expert services to accelerate clinical trials and improve data-driven decisions. Our core expertise includes Electronic Data Capture (EDC) development, seamless systems integration, AI deployment, clinical data science, and project management. We deliver actionable insights with intuitive data visualization tools and custom dashboards that streamline clinical processes. As an ISO-certified and Medidata Rave-accredited organization, ClinFocus is dedicated to maintaining the highest quality standards while fostering trust and innovation.

Role Description

This is a contract-based remote role for a Clinical Data Manager. The Clinical Data Manager will oversee and manage the end-to-end data lifecycle for clinical trials, ensure data quality, perform data validation, and support clinical data management activities. The role includes collaborating with clinical teams, building and testing Electronic Data Capture (EDC) systems, and providing insights for decision-making through effective data management.

Qualifications

• Proficiency in Data Management and Data Validation processes to ensure accuracy and compliance
• Experience with Clinical Data and Clinical Data Management methodologies to support clinical trials
• Hands-on expertise in Electronic Data Capture (EDC) systems and related tools
• Ability to analyze and interpret clinical trial data for informed decision-making
• Strong organizational, communication, and problem-solving skills
• Bachelor's degree in Life Sciences, Computer Science, or a related field
• Familiarity with industry regulations and standards, including FDA, GCP, and CDISC, is a plus
• Previous experience in a remote work environment is advantageous

linical Data Manager

Role Overview:

Provides leadership and expertise in all aspects of Data Management.

Key Responsibilities:

• Develop and review data management procedures for clinical trials with sponsor companies and other departments.

• Design reports and metrics that are useful management tools for projects.

• Lead the design and validation of the CRF specifications and edit checks for each study's electronic data capture system.

• Attend and participate in teleconferences and face-to-face meetings with sponsor companies as the lead representative from data management.

• Creates and oversees EDC build and database lock timelines to maintain on-time deliverables.

• Manage multiple projects and associated project team members; and

• Ensure DM project deliverables are completed on time and by quality standards and requirements from study startup through study closure/archival.

• Perform thorough development testing of the eCRF before deployment, inclusive of creating a User Acceptance Test (UAT) Plan, testing scripts, and executing testing as applicable.

• Participates in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells.

• Perform supplemental data reviews according to the data quality checks outlined in the data quality review plan.

• Participate in reviews of blinded TFL output before final database locks.