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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