Clinical Data Associate II

Project Farma (PF); Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Precision Medicine Group in Bengaluru, India is seeking a Clinical Data Associate II to support data management across clinical trials from start-up to post database lock under supervision. You will assist in database development, testing, and QA of data entry and edit checks in line with study SOPs and regulatory guidance.

You will back up Lead DM, coordinate with sponsors and vendors, prepare CRF specifications, UAT, line listings, SAS programming support, and maintain data management

Qualifications

• Bachelors and/or a combination of related experience.
• 2 to 4 years' experience in clinical data or related fields.
• 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 English language; both written and oral.

Responsibilities

• Support the Lead DM as a back-up and/or team member, ensuring continuity and timely task completion.
• May perform data entry for paper-CRF studies and quality control of data entry.
• Develop CRF specifications from the protocol and coordinate stakeholder feedback.
• Assist in building clinical databases and conduct database build UAT.
• Specify requirements for edit checks and maintain data management documentation.
• Train clinical research personnel on CRF, EDC, and related items as needed.
• Review and query data according to the Data Management Plan.
• Run line listings and report patient and study level metrics.
• Medical coding and SAE/AE reconciliation coordination.
• Liaise with external vendors in a project-manager capacity; SAS programming support may be needed.
• Identify and troubleshoot operational problems based on metrics and audits.
• Contribute to SOPs and process documentation for data management activities.
• Communicate with sponsors, vendors, and project teams regarding data issues.

Skills

Organizational skills

Communication skills

English proficiency

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Job description

Job Description

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

Minimum Required

• 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

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