Job Opportunity: Associate Clinical Data Manager (Hybrid)

Job Summary

Statistics & Data Corporation (SDC) is seeking a detail-oriented and experienced professional to join our team as an Associate Clinical Data Manager in Hyderabad. This is a full-time, hybrid position ideal for candidates with a background in life sciences or pharmacy who are looking to advance their careers within a global Contract Research Organization (CRO). The successful candidate will play a pivotal role in the clinical data management lifecycle, ensuring high-quality data integrity for international clinical trials.

Company Overview

Since 2005, SDC has been a leader in clinical research, providing specialized services driven by innovation and clinical technology. We pride ourselves on fostering an environment that encourages career growth, continuous learning, and a healthy work-life balance. By joining SDC, you will gain exposure to global clinical trials and work alongside a team of dedicated professionals committed to advancing medical research.

Responsibilities

As an Associate Clinical Data Manager, you will manage end-to-end data activities throughout the study lifecycle:

Study Setup & Design

• Design and review Case Report Forms (CRFs) to ensure they meet project requirements.
• Develop database structures and perform necessary annotations.
• Execute EDC (Electronic Data Capture) setup, validation checks, and system testing.

Study Conduct

• Manage the query resolution process and conduct thorough reviews of data listings.
• Oversee data transfers and perform routine quality control checks to ensure accuracy.
• Maintain strict adherence to ICH-GCP guidelines and regulatory standards.

Study Closeout

• Provide essential support during database lock activities.
• Ensure all documentation meets high-quality standards for regulatory submission.

Project & Team Support

• Assist in monitoring project timelines, budgets, and deliverables.
• Provide mentorship and guidance to junior Clinical Data Associates.
• Collaborate effectively with cross-functional teams and external clients to ensure project success.

Requirements

We are looking for candidates who possess a blend of technical expertise and analytical skills.

Educational Qualifications

• A Master’s degree in Life Sciences, Pharmacy, or Engineering with at least 1 year of relevant clinical data management experience.
• Alternatively, a Bachelor’s degree in a relevant field with 3+ years of professional experience in clinical trials.

Key Skills & Experience

• Comprehensive understanding of clinical trial protocols and the data management lifecycle.
• Hands-on experience with EDC systems.
• Proficiency in CRF design, query management, and data validation processes.
• Strong knowledge of ICH-GCP and FDA/CFR regulatory guidelines.
• Experience with medical coding review.
• Excellent proficiency in MS Office suite and MS Project.

Benefits

• Competitive Compensation: An estimated salary range of ₹5.5 LPA – ₹9.5 LPA, commensurate with experience.
• Flexible Work Environment: A hybrid work model designed to support a healthy work-life balance.
• Career Development: Opportunities for promotion and professional growth within a global organization.
• Global Exposure: The chance to work on diverse international clinical trials.
• Supportive Culture: An innovation-driven workplace that values employee contributions and professional well-being.

Job Location

Hyderabad, Telangana, India (Hybrid).

How to Apply

If you are a dedicated professional looking to make an impact in the field of clinical data management, we invite you to apply for this position. Please submit your updated resume and cover letter via our official application portal. Ensure that your application highlights your relevant experience with EDC systems and your familiarity with clinical regulatory guidelines.

We look forward to reviewing your application and potentially welcoming you to the SDC team.