9 publicaciones de empleo destacadas de external audit en microcentro, b (¡Están contratando!)

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Clinical Trial Manager - Sponsor Dedicated

IQVIA -
Buenos Aires, Buenos Aires

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Detalles del empleo

Tiempo completo

Descripción completa del empleo

Buenos Aires, Argentina | Full time | Home-based | R1562244

Internal Job Description

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.

Where you'll work

Home-based

You’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.

Culture

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.

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