The Clinical Data Manager is required to manage clinical research data in department of Clinical Research studies. He or she is responsible for the updating, maintenance and validation of clinical study databases and for the provision of computerized reports of these data.

He or she is a key member of the clinical project team and should be able to prioritize work in line with project management decisions. The responsibilities of the Clinical Data Manager is to manage clinical trials through review, , cleaning and auditing of clinical data and data bases in compliance with standard operating procedures, client guidelines and regulatory agency guidelines.

This position reports to: The VP Clinical Operations & Quality Compliance

Responsibilities:
The main responsibilities of this role include, but are not limited to:

• Review, analyze, and validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines
• Review and approve CRF design, data review ground rules and database design according to Standard Operating procedures and protocol
• Assist in standardizing data management procedures such as documentation for departmental operating procedures
• Develop and maintain documentation and data management guidelines
• Maintain clinical trial data accuracy through review of case report forms for completeness and consistency
• Assist in the development and implementation of strategy for data cleaning and in the design and programming of clinical databases
• Query data inconsistencies and revise case report forms in compliance with standard operating procedures, client guidelines and regulatory agency guidelines
• Generate data retrievals and summaries

Education & Experience:

• Bachelor’s degree in scientific or relevant discipline
• At least 4 years of experience in the Clinical Research Industry and Clinical Data Management.
• Knowledge of relevant GCP regulations and pertinent ICH guidelines
• Strong interest in clinical research and have an affinity with working with databases
• Experience with biopharmaceutical company, CRO or academic setting
• Experience with clinical trial electronic data capture systems and processes is an asset
• Experience with clinical drug development process and knowledge of FDA regulatory requirements
• Experience with multi-site and multiple clinical trials supply support globally

Skills & Competencies:

• Ability to work unsupervised taking responsibility for own actions
• Experience with InForm or Rave desired
• Work precisely according to procedures, rules and regulations
• Recognize recurring issues and analyze their causes in order to reach a solution
• Consistency in delivering positive results, following tasks through from start to finish
• Excellent verbal and written communication skill

To apply, please submit your Cover Letter and Resume to info@eclipsesol.com