Opening for the post of Clinical Data Associate - Trainee @ Clinipace

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 12 offices in eight countries. Our proprietary technology (TEMPO™ eClinical platform) 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.
Location: Trivandrum, India
Job Code: M1217-1
Description
The Clinical Data Associate Trainee assists the Clinical Data Manager with the process of cleaning and validating data in clinical trials in accordance with Clinipace Worldwide SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.
Locations preferred: Trivandrum, India (Office based)
Job Duties and Responsibilities for the Clinical Data Associate:
The specific job duties of a Clinical Data Associate may include but are not limited to:
Assists with reviewing and processing Data Clarification Forms, reviewing data listings and quality control reports and updating clinical databases.
Assists with Data Entry and Reconciliation as needed or assigned.
Assists with start-up activities including:
Creation and entry of test data for data entry screen validation
Set up of patient and investigator information
For specified projects assists on 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
Assists with maintaining and updating Data Management Plans and any other relevant Data Management Documentation.
Participates in assigned study finalization activities including:
Database close-out
Reconciliation
Critical item review
Quality Control
Archiving.
Participation in appropriate project team meetings.
Manages time in accordance with allocated hours for task.
Participates in departmental and organizational meetings and initiatives.
Supervisory Responsibilities: No supervisory responsibilities.
Job Requirements for the Clinical Data Associate:
Education
College graduate with a life science, computing or nursing qualifications preferred, or 3 to 4 years equivalent experience
Experience
Experience with medical terminology preferred.
License/Certification
N/A
Skills/Competencies
Excellent organizational skills
Strong written and verbal communication skills
Exceptional attention to detail
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 here to apply
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 12 offices in eight countries. Our proprietary technology (TEMPO™ eClinical platform) 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.
Location: Trivandrum, India
Job Code: M1217-1
Description
The Clinical Data Associate Trainee assists the Clinical Data Manager with the process of cleaning and validating data in clinical trials in accordance with Clinipace Worldwide SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.
Locations preferred: Trivandrum, India (Office based)
Job Duties and Responsibilities for the Clinical Data Associate:
The specific job duties of a Clinical Data Associate may include but are not limited to:
Assists with reviewing and processing Data Clarification Forms, reviewing data listings and quality control reports and updating clinical databases.
Assists with Data Entry and Reconciliation as needed or assigned.
Assists with start-up activities including:
Creation and entry of test data for data entry screen validation
Set up of patient and investigator information
For specified projects assists on 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
Assists with maintaining and updating Data Management Plans and any other relevant Data Management Documentation.
Participates in assigned study finalization activities including:
Database close-out
Reconciliation
Critical item review
Quality Control
Archiving.
Participation in appropriate project team meetings.
Manages time in accordance with allocated hours for task.
Participates in departmental and organizational meetings and initiatives.
Supervisory Responsibilities: No supervisory responsibilities.
Job Requirements for the Clinical Data Associate:
Education
College graduate with a life science, computing or nursing qualifications preferred, or 3 to 4 years equivalent experience
Experience
Experience with medical terminology preferred.
License/Certification
N/A
Skills/Competencies
Excellent organizational skills
Strong written and verbal communication skills
Exceptional attention to detail
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 here to apply
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