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Job for Clinical Data Manager at Clinipace

 

Clinical courses

Clinipace Worldwide is a different kind of CRO, where people are the backbone of our technology-amplified processes.  We are a global full-service digital Clinical Research Organization (dCRO) and one of the fastest growing companies in America.  Clinipace currently has a global footprint of 31 offices in 25 countries.  Our proprietary technology combined with an innovative service model transforms drug and medical device development.  We are proud to have a culture that is vibrant, supportive, performance-driven, and passionate while focusing on continual learning and development.  Our associates are passionate about their lives and bring that same passion to their work at Clinipace Worldwide.

Post : Clinical Data Manager I

Job Duties and Responsibilities: 
The specific job duties of a Clinical Data Manager I may include but are not limited to:     
For specified projects performs start-up activates including:        
Developing data management guidelines and study documentation        
Review of CRF design against protocol        
Review of database setup    

For specified projects performs some data management activities as detailed below and performs activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.        
Study status tracking        
Data Entry        
Review of data listings        
Identification of data issues and query generation        
Updating of database with query resolutions (on paper studies only)        
Archiving of critical documents on an ongoing basis    

Participate in User Acceptance Testing for assigned projects    
For specified projects performs study finalization activities including:        
Database close-out        
Critical item review        
Quality Control        
Archiving

 

Job Requirements:     
Education

College graduate with  a life science, computing or nursing qualifications  preferred, or 3 to 4 years equivalent experience.
Experience
Minimum of 2 years of experience and or demonstrated aptitude for data management work.
Experience working in pharmaceutical and/or Contract Research Organization (CRO) industry preferred
Working knowledge of EDC studies
License/Certification- N/A

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Skills/Competencies
Excellent organizational skills        
Strong written and verbal communication skills      
Exceptional attention to detail        
Technology Proficiency including Data Management Systems        
Study documentation production and maintenance, data processing, data review        
Knowledge of clinical research including regulatory requirements GCP/ICH        
Study management activities        
Data Quality        
Strong computer skills, including Microsoft Office        
Good problem-solving skills    

Capabilities
Flexibility - willing to change assignments and work focus to accommodate project demands        
Team player – effective proactive participant as a team member.        
Work evening and/or weekends on occasion as needed by the project

Additional Information:
Experience: Min 2 years
Qualification: Graduate with  a life science
Location:  Trivandrum, India
Industry Type: Pharma
Functional Area: CR
Last date : 15th January, 2017

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