Maintenance Lead, Clinical Research

Study Maintenance Lead

LATAM - Home-based

Job Overview
The Maintenance Lead is responsible for leading the strategic operational and financial delivery of clinical study maintenance activities ensuring the timely implementation of revised clinical study documents regulatory submissions approvals and associated site maintenance activities. This role provides project leadership stakeholder management and regulatory oversight to ensure studies remain compliant on schedule and aligned with sponsor and company requirements.

Key Responsibilities

• Lead the execution of lifecycle maintenance activities for assigned clinical studies ensuring compliance with ICH-GCP regulatory requirements sponsor expectations and company policies.

• Develop and implement maintenance strategies plans timelines and deliverables to support efficient study execution.

• Provide project oversight for amendments regulatory submissions ethics approvals essential document updates and site contract modifications.

• Collaborate with internal and external stakeholders to resolve issues manage risks and ensure successful delivery of study objectives.

• Review regulatory requirements and provide strategic guidance on submissions approvals and maintenance activities across regions.

• Maintain accurate project documentation tracking systems reports and study records.

• Support business development activities including bid defenses proposal development and transitioned studies.

• Build and maintain strong client relationships providing regular updates and contributing to customer-focused initiatives.

• Mentor and coach team members supporting capability development and knowledge sharing.

• Drive continuous improvement initiatives that enhance operational efficiency and study delivery.

Qualifications & Experience

• Bachelors degree in Life Sciences or a related field.

• Minimum 5 years experience in a clinical research regulatory or scientific environment.

• At least 2 years of leadership or project lead experience.

• EAC financial experience required.

• Demonstrated experience working in a global or international environment.

• Strong knowledge of clinical trial regulations study maintenance processes and project management principles.

• Excellent communication stakeholder management and problem-solving skills.

Experience Level: Mid-Senior Level
Function: Clinical Operations / Study Maintenance / Regulatory Affairs

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

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