Clinical Data Specialist
Clinical Data Specialist
Posted on :
20-01-2025
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1 Vacancy
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Job Description
Job Title: Clinical Data Specialist
Job Location: Bengaluru Karnataka India
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience Fortrea provides pharmaceutical biotechnology and medical device customers a wide range of clinical development patient access and technology solutions across more than 20 therapeutic areas. Conducting operations in 100 countries Fortrea is transforming drug and device development for partners and patients across the globe.
Job Overview
Serve as a member of the project team with primary responsibility for conducting the clinical data review query generation / resolution and reconciliation activities to support the Data Management lead with the delivery of clinical data according to client quality and integrity specifications project timelines and productivity targets. Assist in the development of the project Data Management Plan including data review guidelines /edit check and eCRF specification. May contribute to setup of the data management systems according to project requirements.
Summary Of Responsibilities
Fortrea Is Proud To Be An Equal Opportunity Employer
As an EOE/AA employer Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race religion color national origin gender (including pregnancy or other medical conditions/needs) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data please see our Privacy Statement.
If you require a reasonable accommodation to complete your job application preemployment testing job interview or to otherwise participate in the hiring process please contact: . Please note that this email address is only for job seekers requesting an accommodation. Please do not use this email to check the status of your application.
Job Overview
Serve as a member of the project team with primary responsibility for conducting the clinical data review query generation / resolution and reconciliation activities to support the Data Management lead with the delivery of clinical data according to client quality and integrity specifications project timelines and productivity targets. Assist in the development of the project Data Management Plan including data review guidelines /edit check and eCRF specification. May contribute to setup of the data management systems according to project requirements.
Summary Of Responsibilities
- Ensures that all allocated projects are carried out in strict accordance with the relevant protocols global harmonized SOPs and the specified standards of GCPs.
- Demonstrates capability to read and follow study timelines for ontime deliverables.
- Potential to assist with inputs on study design or capable to make suggestions to study timelines when warranted.
- Assist with review of clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous missing incomplete data.
- Run and execute additional programs (special listings reconciliation discrepancy listings etc.) used to support the review of clinical trial data.
- Generate resolve and track queries to address problematic data identified during aggregate data review activities.
- Interacts with other project team members to support the setup maintenance and closure of the Data Management aspects of the project and attend meetings as required.
- Generate and QCs data listings for internal data review.
- May assist or create dummy data to test edit checks and to test database screen design and functionality.
- Assist or create dummy data to test SAS reports and data listing.
- Demonstrates the ability to review Edit Check Specifications and Database specifications.
- Post Data Management documentation and data management related administrative tasks as requested including maintenance of eTMF as required.
- Runs study status reports in preparation for Sponsor meetings and to deliver on specific Sponsor request.
- Assist with the completion of Database Lock and Unlock activities.
- Supports the training of new staff on project specific Data Management processes.
- Performs any other duties as assigned.
- University / college degree (life sciences health sciences information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.
- Fluent in English both written and verbal.
- 3 to 5 years of relevant work experience with increasing responsibility in data management with knowledge of one (1) or more therapeutic areas.
- Demonstrated time management skill and ability to adhere to project productivity metrics and timelines.
- Knowledge of medical terminology is preferred.
- Knowledge of effective clinical data management practices.
- Knowledge of science or a scientific background is preferred.
- Good oral and written communication skills.
- Demonstrate time management skill and ability to adhere to project productivity metrics and timelines.
- Demonstrate ability to work in a team environment and collaborate with peers.
- Demonstrate good organizational ability communication and interpersonal skills.
- Demonstrate team working skills and good collaborator skills.
- Demonstrate a constructive problemsolving attitude while deadline focused with time demands incomplete information or unexpected events.
- Knowledge of Fortrea and the overall structure of the organization.
- Knowledge of Fortrea standard operating procedures.
- Office and/or homebased work environment.
- May require overtime and weekend work as required.
- Should be willing to work in flexible shifts as per business requirement.
Fortrea Is Proud To Be An Equal Opportunity Employer
As an EOE/AA employer Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race religion color national origin gender (including pregnancy or other medical conditions/needs) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data please see our Privacy Statement.
If you require a reasonable accommodation to complete your job application preemployment testing job interview or to otherwise participate in the hiring process please contact: . Please note that this email address is only for job seekers requesting an accommodation. Please do not use this email to check the status of your application.
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Employment Type
Full Time
Key Skills
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