Clinical Data Management
The Intelligent Solutions - Toronto, ON

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Contact: Dr Richard Hackman, 416-821-9020
JOB TITLE: Clinical Data Management
REPORTS TO: President
DIVISION/UNIT: Clinical Data Management

CLINICAL DATA MANAGER

The Clinical Data Manager will lead assigned data management projects by applying project management skills and data management techniques to ensure timely and quality deliverables to our clients. The incumbent will manage project timelines and coordinate activities for assigned projects, and be responsible for the development of Data Management Plans, clinical trial case report forms, databases, and overseeing data processing and performing database quality control procedures.

A bachelors' degree in health science, registered nurse, or higher equivalent education in relevant disciplines, with a minimum of 4 years experience in clinical trial data management, and demonstrated leadership ability to effectively manage clinical trial data management activities and integrate them with the entire clinical trial operations; must communicate effectively, orally and in writing. Experience with clinical trial electronic data capture systems and processes is an asset. Solid understanding of clinical drug development process and knowledge of FDA regulatory requirements and ICH/GCP guidelines is required. In addition, the incumbent must have excellent oral and written communication skills and to apply such skills in logical and algebraic operations. Bi-lingual in French and English is an asset.
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SENIOR CLINICAL DATA MANAGER

The Senior Clinical Data Manger is the key contact person for data management activities for multiple pharmaceutical sponsor companies. The incumbent will be accountable for performing data processing and management activities for assigned projects. This will involve such activities as: design and review patient Case Report Forms and database schema; test data capture/entry screens; review CRFs and generate data query reports; follow up with study sites to resolve queries; assist in resolving data coding discrepancies; perform quality control audits on assigned databases during the trial and additional database closure checks at the end of the study; validate and disseminate real-time study monitoring reports to study team members; perform coding for Adverse Events using MedDRA; lead efforts in developing and maintaining standard database integrity checks. In addition the incumbent will be responsible for training on data management processes and procedures with new data management personnel.

A bachelors' degree in health science, physical or biological fields with at least 7 years experience in clinical trial data processing and management. Education and experience must demonstrate leadership ability and the ability to effectively work independently. The incumbent must have a proven track record in managing clinical trial data management activities, applying data management concepts, clinical trial data processing techniques, and integrating them with the entire clinical trial operations. Experience with clinical trial electronic data capture systems and processes is an asset. Solid understanding of clinical drug development process and knowledge of FDA regulatory requirements and ICH/GCP guidelines is required. In addition, the incumbent must have excellent oral and written communication skills and to apply such skills in logical and algebraic operations. Bi-Lingual in French and English is an asset.


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