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Actalent Clinical Data Manager (REMOTE) in Boston, Massachusetts

A leading Biotech company in Boston, MA is seeking a Clinical Data Manager to join their team!

· Provide leadership and direction in management of third-party vendors such as CROs in support of timelines and data-related deliverables, and adherence to overall standards for consistency and efficiency

· Identify and troubleshoot operational problems, issues, obstacles, and barriers for study success based on metrics data, audit reports, and input from project team members and other stakeholders

· Regularly review clinical trial data within Medidata Rave EDC to confirm data quality. Develop and execute internal procedures for data quality review and data acceptance prior to data analyses and/or database lock.

· Work within and across functions to manage and optimize timelines and ensure that clinical data management deadlines are met and in high quality

· Work with database builders to develop EDC databases, Case Report Forms, edit checks, and reports, listings, and visualizations in support of protocol execution and study analyses. Conduct testing according to the UAT Plan.

· Orchestrate seamless integration and functionality of additional data management technologies as needed, including randomization, trial supply management, e-consent, and patient facing clinical outcome assessment tools.

· Review and provide feedback on draft protocols, Statistical Analysis Plans, CSRs and other clinical trial documents as required

· Train personnel on EDC, as needed

Requirements and Qualifications

· Bachelor’s degree or equivalent in a health-related field

· 5+ years of experience in clinical data management in the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA-regulated environment

· Proficiency in the area of clinical data collection, cleaning, and analysis

· Demonstrated excellence working in cross-functional, team-oriented environments

· Strong project management skills

· Extensive experience managing CROs and/or other data vendors

· Understanding of ICH and regulatory environment as it pertains to data management

· Proficiency working in Medidata Rave EDC system and experience using other integrated Medidata products

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.