Job Title: Clinical Data Manager I
Job Location: Trivandrum, India
Job Overview:
The Clinical Data Manager I participates in the clinical data management activities for a project under the supervision of more senior staff; including processing of case report form (CRF) and electronic data in accordance with Clinipace Worldwide SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.
Job Duties and Responsibilities:
The specific job duties of a Clinical Data Manager I may include but are not limited to:
Supervisory Responsibilities: This job involves no supervisory responsibilities for other employees or contractors.
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
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
Click on THIS link to apply.
Job Location: Trivandrum, India
Job Overview:
The Clinical Data Manager I participates in the clinical data management activities for a project under the supervision of more senior staff; including processing of case report form (CRF) and electronic data in accordance with Clinipace Worldwide SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.
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
Supervisory Responsibilities: This job involves no supervisory responsibilities for other employees or contractors.
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
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
Click on THIS link to apply.
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