Lead - Clinical Data Integration and Compliance Project Manager

Job Overview

We are seeking a lead professional to guide clinical data integration initiatives and execute GxP-compliant clinical system implementations. The role encompasses driving projects to completion within deadlines while ensuring premium quality and regulatory compliance.

Key Responsibilities

• Direct end-to-end clinical data integration and clinical system deployment projects with strict adherence to GxP standards.
• Handle comprehensive project management activities including planning, progress monitoring, risk management, and reporting.
• Maintain rigorous compliance with ICH-GCP guidelines, GxP standards, and 21 CFR Part 11 regulations throughout project lifecycles.
• Engage collaboratively with clinical data management teams, electronic data capture (EDC) specialists, data engineers, QA/CSV personnel, and subject matter experts from client organizations.
• Supervise critical processes such as data mapping, transformation logic creation, validation tasks, and testing phases within workflow management.
• Analyze and enhance clinical data pipelines by leveraging automation technologies to streamline operations.
• Facilitate change control initiatives, manage documentation, deliver training to stakeholders, and prepare for audits.

Required Qualifications and Experience

• Possession of PMP certification is mandatory.
• A minimum of five years of experience in IT project management, preferably including digital transformation projects.
• Demonstrated expertise in managing clinical trial data workflows and clinical data management projects.
• In-depth understanding of regulatory compliance related to ICH-GCP, GxP, and 21 CFR Part 11.
• Hands-on experience with clinical data automation tools and electronic data capture systems.

Eligibility

Open to candidates holding any graduate degree.