The Clinical Data Manager is responsible for overseeing all data management activities pertaining to the conduct of Phase I-IV clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met.

Job Responsibilities

Participate

• * T As the primary data management representative on the QED multidisciplinary project teams.
• As the primary point of contact for all data management interactions with the Sponsor.
• In protocol developments and review
• In review of clinical study reports and statistical analysis plan
• In the development of data dictionaries complete with variables, value specifications and coding standards
• In monitoring the quality of data management processes, data and performance

Review and provide

• * Inputs to CRF design and CRF Completion Instructions
• Database design, data management/data validation plans and data entry guidelines
• Revisions to the Standard Operating Procedures

Manage

• * Resource planning methodologies and project management
• To ensure study deliverables and timelines are met in collaboration with the Sponsor
• The Sponsor change order process
• To ensure effective communication exchange between the multidisciplinary project teams

Assist/Work with Sr. Management

• * In identifying, developing and implementing processes to improve/enhance time and cost efficiencies
• To provide current information and potential impact of changes on project deliverables and timelines
• To identify trouble-shoot issues and provide proposed solutions for problem resolution
• To evaluate future potential data management solutions (e.g functional service provider models, EDC systems) and prepare a business plan
• To individual development, training, knowledge and expertise through research, technical bulletins and attending appropriate seminar
• Endorse and convey QED's corporate mission statement

Qualifications/Experience

• Bachelor's/Master's degree in a computer science, statistics, clinical research, biotechnology, from an appropriately accredited institution..
• Minimum of 5 years of data management experience
• Project management experience is required.
• Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required.
• Direct management of employees within Clinical Data Management is preferred.