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Tuesday, 15 March 2016

Clinical Data Manager

1 - 2 YearsPune, Mumbai

Job Description

Responsibilities 

Perform data review and query generation
Define edit checks to be programmed for the study/project
Review programmed edit checks
Track study progress and issue periodic status reports
Update the database to correct errors
Code Case Report Form (CRF) verbatim terms using inVentiv Health Clinical or sponsor supplied dictionaries
Process electronic data received from outside vendors
Identify the achievement of milestones to the project team or Lead Clinical Data
Manager, e.g., database status as "draft" or "final"
Participate in the completion of all quality control measures necessary for the finalization and transfer of the database and related materials to the sponsor
May act as the Lead Clinical Data Manager for assigned studies or projects
May coordinate the work of Associate Clinical Data Managers assigned to the project
May provide training on data management procedures and systems
May create the data management plan for the study/project
May assist in the review of the database design
May develop and design CRFs, or participate in the review of sponsor-generated CRFs

Requirements 

Bachelor's Degree or RN; in lieu of Bachelor's Degree or RN, four years experience in clinical research, drug development, or other healthcare environment, including eighteen months experience in data management
One year of relevant clinical or data management experience
Proven data management skills
Effective communication skills

Company Profile

inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients' therapies to market

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