Clinical Trial Manager - Sponsor Dedicated

IQVIA; São Paulo; Presencial; BRL 180 000 - 280 000; Tempo integral

Resumo da oferta

IQVIA Brazil seeks a Clinical Trial Manager – Sponsor Dedicated to oversee local trial management from startup to closeout, ensuring GCP adherence and regulatory compliance across country teams.

The role requires a BA/BS, 2+ years local trial management experience, and ability to forecast budgets, manage contracts, and liaise with health authorities. Strong IT skills and English plus local language proficiency are expected.

Qualificações

• BA/BS degree required.
• Degree in health or science field required.
• Minimum 2 years of local/regional trial management experience in pharma industry or CRO; prior Clinical Research Associate experience preferred.

Responsabilidades

• Adhere to Sponsor SOPs, WIs, GCP, and local regulations.
• Prepare or contribute to budget estimates and detailed proposals; manage ESP contracts and changes.
• Act as primary country contact for assigned trial and monitor progress against timelines.
• Maintain trial management systems and use reports to analyze progress; support HA inspections and audits.
• Contribute to site-level recruitment strategy and contingency planning.
• Review country-specific informed consent in line with SOPs and templates.

Conhecimentos

Trial management experience

Budget forecasting

Regulatory compliance (GCP/ICH)

Communication skills

Formação académica

BA/BS degree

Health/science degree

Ferramentas

Trial management systems

Descrição da oferta de emprego

Clinical Trial Manager – Sponsor Dedicated

Clinical Project Management services provide management of clinical trials at a local level. Services/deliverables include operational oversight of assigned project(s) at the local level for end-to-end project management from start-up through to closeout activities.

Tasks & Responsibilities

• Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements.
• Prepares or contributes to high level budget estimate in response to Request for Service’s followed by detailed budget proposal. Ensures overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
• Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits. Escalates corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Contributes to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.

Essentials Requirements

• BA/BS degree.
• Degree in a health or science related field.
• Minimum of 2 years of local/regional trial management experience in the pharmaceutical industry or CRO and previous experience as Clinical Research Associate.
• Specific therapeutic area experience may be required depending on the position.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.
• Excellent decision-making and strong financial management skills.
• Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.