Manager, Data Management

Proclinical, in support of our client, are seeking an individual to fill the role of Clinical Data Management Manager, based in New Jersey.

Responsibilities

• Review protocols to reporting requirements can be met and are standardized across the program.
• Coordinate CRF design as per established standards and applicable protocol.
• Maintain timelines for database and edit check development in alignment with first subject, first visit, as well as end of study timelines to align with last subject, last visit.
• Review data management and study documents to ensure quality and standardization; anticipate issues and address resolution or suggest risk minimization methods applicable to the situation.
• Work with CROs, vendor(s) and other suppliers in supporting the DM tasks through study lifecycles.
• Collaborate with vendors on the license agreement requirements for utilizing questionnaires and rating scales and the translations for multiple languages within programs.
• Develop, review and revise global Standard Operating Procedures (SOPs); provide team training.
• Oversee and review day-to-day management of clinical data. Review data-associated metrics.
• Oversee clinical coding process of coded terms ensuring consistency throughout the compound/studies.
• Document, verify, validate and execute regulatory compliant programs to perform clinical data management activities.
• Guide teams to capture data using methods such as Electronic Data Capture.
• Guarantee that data transfer requirements and deployment of clinical trial sites are well defined.
• Coordinate with clinical research and database analysts in clinical trial databases' design, development, testing and documentation.
• Ensure the accurate tracking of all CRFs and DCFs and the identification of any missing information.
• Use problem solving and judgment to apply Clinical Data Management principles.
• Oversee development of and compliance with global library standards.
• Develop and maintain the Data Management Plan, Data Cleaning specifications, and other Data Management documentation.
• Work with the quality control team to ensure quality of data management projects.

Skills And Qualifications

• BA in a relevant scientific field and 3-5 years of prior experience in data management, or MA in a relevant field with 1-3 years of data management experience.
• 1-3 years' experience in ophthalmology studies.
• Experience in CRO and vendor management.
• Knowledge of medical terminology and experience with multiple phases of clinical trial process.
• Experience with all aspects of data management.
• Proficiency in Microsoft Office suite.
• Expert level proficiency in data management systems, processes, tools, and procedures.
• Certified Clinical Data Manager (CCDM) Certification.
• Excellent written, verbal, and interpersonal communication skills.
• Moderate travel may be required.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 646-878-6308 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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