Clinical Trial Manager - Sponsor Dedicated at IQVIA

São Paulo, State of São Paulo, Brazil

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

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

Responsibilities

Adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements
Prepare or contribute to high level budget estimate in response to Request for Service’s followed by detailed budget proposal
Ensure overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensure services are delivered per contract
Act as primary company contact for assigned trial at the country level and ensure local/country team is tracking project progress against planned timelines and monitor patient recruitment rate to ensure that target enrollment will be met across the allocated countries
Develop 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
Participate in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits
Escalate corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicate study progress and issues to study management teams and business partners
Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target
Contribute to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates, including reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations

Skills

GCP

Project Management

Budget Management

Contract Management

Patient Recruitment

Risk Management

Trial Management Systems

CAPA

Regulatory Compliance

HA Inspections

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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