Clinical Data Associate II

Precision Medicine Group, LLC.; Bengaluru; Presencial; INR 600.000 - 900.000; Jornada completa

Descripción de la vacante

Precision Medicine Group, LLC. in Bangalore, India, is seeking a Clinical Data Associate II to provide data management support across the lifecycle of multiple clinical trials under supervision.

You will back up the Lead DM, build or review CRF specifications, assist with database development, QA data, generate line listings and reports, coordinate with sponsors and vendors, and help ensure data integrity and timely delivery. 2–4 years of experience and strong MS Office skills are preferred.

Formación

• Bachelor's degree or related experience.
• 2 to 4 years’ experience in clinical data management or related field.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Excellent organizational and communication skills; professional English.
• Able to manage multiple tasks and work under supervision.

Responsabilidades

• Provide data management support across the clinical trial lifecycle.
• Back up Lead DM and ensure timely task completion.
• May perform data entry for paper-CRF studies; QA of data.
• Develop CRF specifications from study protocol; coordinate feedback.
• Assist in building databases; conduct database build UAT.
• Specify edit checks and maintain DM documentation.
• Train study personnel on CRF/EDC; review data per DM plan.
• Run line listings and study-level status reports; perform data coding.
• Coordinate SAE/AE reconciliation and liaise with vendors as needed.
• May assist SAS programming and QA of SAS programs.
• Participate in SOP development and process documentation.
• Communicate with sponsors, vendors, and project teams; present trainings.

Conocimientos

Excellent organizational skills

Excellent communication skills

Professional use of English

Educación

Bachelor's degree or related experience

Herramientas

Microsoft Office

Descripción del empleo

Location: Bangalore, Karnataka, India
Category: Clinical Trial Services
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 7287

Position Summary

The Clinical Data Associate II provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position may perform database development and testing, as well as additional data management activities.

Essential functions of the job include but are not limited to

• Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner
• May perform data entry for paper-CRF studies, as needed
• May perform quality control of data entry
• May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation
• Assist in specifying requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed
• Review and query clinical trial data according to the Data Management Plan
• Assist in line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Assist with coordinating SAE/AE reconciliation
• Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• May assist in identifying and troubleshooting operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned

Qualifications

• Bachelors and/or a combination of related experience

Other required:

• 2 to 4 years’ experience
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral

Preferred:

• Experience in a clinical, scientific or healthcare discipline

Candidates must be legally authorized to work in the country of employment without employer sponsorship.

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If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail] .