Clinical Data Manager
Posting ID: JP-002187156
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
Amazing begins here. EASi is a leading global services company specializing in engineering and sciences. For more than 35 years, EASi has delivered critical services across a range of industries, including energy and utilities, transportation, heavy equipment, consumer and industrial products, medical devices, pharmaceutical and biotechnology, as well as academic and health care research. By adapting to the constantly evolving needs of our customers, we have built specialized expertise and a multidisciplinary perspective - leveraging cutting-edge technology and processes - to constantly improve and innovate. Through EASi's flexible solutions and consultative approach, customers in engineering and sciences can expect unparalleled quality, increased speed to market and collaborative customer engagement services.
Headquartered in Hanover, Maryland, EASi has 3,700 dedicated employees across North America, Europe and Asia. EASi is an Aerotek company, a leader in the recruiting and staffing industry. Aerotek is an operating company of Allegis Group® Inc., a global leader in talent solutions. To learn more about EASi, visit EASi.com.
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.
Recruiter: Joseph Flanigan
Phone: (617) 535-3180