Clinical Trial Manager - Sponsor Dedicated PCD

IQVIA; São Paulo; Presencial; BRL 180 000 - 240 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Clinical Trial Manager to oversee sponsor-dedicated trials at the country level in Brazil. The role ensures adherence to GCP, local regulations, and country SOPs, driving enrollment plans and study milestones.

The position requires a BA/BS in a health or science field, 2+ years local/trial management experience, and strong budgeting, regulatory, and communication skills. Some travel may be required, with focus on sponsor-driven objectives.

Qualificações

• BA/BS degree or higher in health or science field.
• Minimum 2 years local/regional trial management experience.
• Knowledge of ICH-GCP and regulatory requirements.
• Willingness to travel with overnight stays.
• Proficient in English and local language.

Responsabilidades

• Act as primary country contact and monitor study progress against timelines.
• Oversee local patient recruitment and contingency planning.
• Manage budgets, contracts, and change orders.
• Support study management with CAPA and QA inspections.
• Review country-specific informed consent forms and patient safety.

Conhecimentos

IT skills

Decision making

Financial management

Communication skills

Formação académica

BA/BS degree

Health/science degree

Ferramentas

Clinical trial management systems

Descrição da oferta de emprego

Clinical Trial Manager – Sponsor Dedicated.

Clinical Project Management services provide management of a clinical trial (s) in 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.

• 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.

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 https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Vaga Exclusiva para Pessoa com deficiência (PCD)