Clinical Trial Manager - Sponsor Dedicated

About the role

iQVIA provides clinical project management services for clinical trials at the local level, covering operational oversight from start-up through closeout. As a Sponsor Dedicated Clinical Trial Manager in São Paulo, you act as the primary company contact for the assigned trial at country level and manage the local team's progress against timelines and patient recruitment targets.

Key responsibilities

• Deliver services in line with Sponsor SOPs, WIs, GCP, local regulatory requirements and applicable codes.
• Prepare or contribute to the budget estimate and detailed budget proposal, and manage the contract, including ESP contracts, change orders and delivery against the contract.
• Monitor project progress and patient recruitment, develop local procedures and tools, plan recruitment contingencies and forecast budgets.
• Maintain and update trial management systems, prepare for and take part in Health Authority inspections and internal quality assurance audits, and escalate CAPAs to the relevant management teams.
• Contribute to site-level recruitment strategy and to the review of country-specific informed consent forms and site-specific IC forms.

Required profile

• BA/BS degree in a health or science-related field.
• At least 2 years of local/regional trial management experience in the pharmaceutical industry or CRO, with previous experience as a Clinical Research Associate.
• Specific therapeutic area experience may be required depending on the position.
• Willingness to travel occasionally, including overnight stays.
• Proficiency in the country language and English, with good written and oral communication.

Required skills

• Strong working knowledge of ICH-GCP, company SOPs, local laws and regulations, and assigned protocols.
• Strong IT skills in the relevant software and company systems.
• Excellent decision-making and financial management skills.