Clinical Project Manager - Sponsor Dedicated (FSP)

About the role

iQVIA is looking for a Clinical Project Manager dedicated to a sponsor (FSP) based in Buenos Aires. The role manages clinical trials at local level, providing operational oversight from start-up through to closeout, in line with the sponsor's SOPs, GCP and local regulations.

Key responsibilities

• Prepare or contribute to the high-level budget estimate and detailed budget proposal, and manage the contract, including ESP contracts, change orders and delivery against the contract.
• Act as the primary company contact for the assigned trial at country level, keeping the local team on track against timelines and monitoring patient recruitment to meet targets.
• Develop local trial procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• 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 in line with SOPs and regulations.

Required profile

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

Required skills

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