Clinical Data Associate II – Join Precision for Medicine’s Remote Team in India

Are you a data management professional looking to enhance your career by contributing to the clinical trial data management process? Precision for Medicine is seeking a dedicated and skilled Clinical Data Associate II to play a crucial role in ensuring data accuracy and adherence to industry regulations. If you’re ready to take your expertise to the next level, read on to discover more about this role.

About Precision for Medicine

Precision for Medicine is a company dedicated to advancing life sciences and healthcare by providing innovative solutions for clinical research and data management. With a commitment to precision medicine, they play a vital role in improving patient outcomes and advancing medical knowledge.

Position: Clinical Data Associate II

Location: Remote, India

Type: Full-Time

Position Summary

As a Clinical Data Associate II at Precision for Medicine, you will be a key contributor to the clinical trial data management process. Under direct supervision, you’ll support various aspects of data management, from study initiation to post-database lock. Your role will involve adhering to industry regulations and best practices, ensuring accurate and reliable data management.

Key Responsibilities

Your essential functions as a Clinical Data Associate II include:

• Providing data management support and assistance for clinical trial data management from study start-up to post-database lock, under direct supervision.
• Supporting the Lead Data Manager as a back-up or team member, ensuring tasks are performed timely and maintaining continuity and responsiveness.
• Performing data entry for paper-CRF studies when required and ensuring quality control of data entry.
• Developing CRF specifications based on clinical study protocols and coordinating feedback from stakeholders.
• Assisting in building clinical databases and conducting database build User Acceptance Testing (UAT).
• Specifying requirements for edit check types, including electronic, manual data review, and more.
• Creating, revising, and maintaining data management documentation.
• Training clinical research personnel on study-specific CRFs, EDC systems, and other project-related elements.
• Reviewing and querying clinical trial data according to the Data Management Plan.
• Participating in medical coding of medical terms for logic and consistency.
• Assisting in coordinating Serious Adverse Events (SAE)/Adverse Events (AE) reconciliation.
• Liaising with third-party vendors and external data and EDC vendors as a project manager.
• Assisting with SAS programming and quality control of SAS programs for Data Management.
• Identifying and troubleshooting operational problems for studies based on metrics data, audit reports, and input from stakeholders.
• Reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs), if needed.
• Participating in the development and maintenance of Standard Operating Procedures (SOPs) related to data management.
• Communicating with study sponsors, vendors, and project teams regarding data-related issues.
• Presenting software demonstrations/trainings and participating in project meetings.
• Performing other duties as assigned.

Qualifications

Minimum Required:

• Bachelor’s degree within a scientific/science background, combined with related experience.

Other Required:

• 2+ years of experience in Data Management.
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Ability to handle various data management tasks.
• Strong organizational and communication skills.
• Professional use of the English language, both written and oral.

Preferred:

• Experience in a clinical, scientific, or healthcare discipline.

Why Join Precision for Medicine?

• Innovative Environment: Contribute to advancing clinical research and data management in the healthcare industry.
• Career Development: Grow your skills and expertise in a supportive and dynamic work environment.
• Remote Work Opportunity: Work remotely from India, contributing to global projects.

Apply online