Clinical Trial Manager - Sponsor Dedicated

IQVIA LLC; São Paulo; Presencial; BRL 120 000 - 180 000; Tempo integral

Resumo da oferta

IQVIA LLC is seeking a Clinical Trial Manager for sponsor-dedicated management of local trials. You will oversee start-up through closeout, ensure compliance with GCP and local regulations, and manage budgets and contracts.

The role requires coordinating with country teams to meet enrollment targets and timelines. The ideal candidate holds a BA/BS in a health or science field and has 2+ years of local trial management experience, with strong communication skills in English and the local

Qualificações

• BA/BS degree in a related field.
• Degree in health or science is required.
• Minimum of 2 years local/regional trial management experience.
• Willingness to travel as needed.

Responsabilidades

• Adhere to Sponsor SOPs, WIs, and GCP standards.
• Manage budgets, change orders, and ESP contracts.
• Serve as primary country contact and monitor progress against timelines.
• Maintain trial management systems and report study progress and issues.
• Contribute to site-level recruitment strategy and country-specific procedures.

Conhecimentos

Local trial management

ICH-GCP knowledge

Budget forecasting

Regulatory compliance

Communication skills

Travel willingness

Formação académica

BA/BS degree

Degree in health or science

Ferramentas

Trial management systems

Budgeting tools

MS Office

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.

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 string 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.

No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.