Local Trial Manager at IQVIA

Mexico City, Mexico City, Mexico

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

BA/BS degree in a health or science related field
2 years of clinical trial management experience in the pharmaceutical industry or CRO supporting global or regional trials
Superior clinical research operational knowledge with a proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure
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
Effective leadership skills and ability to manage multiple stakeholders
Proficient in speaking and writing the country language and English
Good written and oral communication skills as appropriate

Responsibilities

Lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones, including country & site feasibility and site selection, trial set-up, trial execution, trial closure, and vendor set up activities as assigned by the Global Clinical Development Operations Trial Leader (GTL)
Adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), and local regulatory requirements
Ensure availability of required reports to support real time tracking of trial status according to trial plan
Manage timely and accurate documentation and communication of trial progress
Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness
Act as primary contact for Country and Regional staff
Act as primary company contact for assigned trial at the country level; ensure local/country team tracks project progress against planned timelines; monitor patient recruitment rate to ensure target enrollment is met across 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 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; communicate study progress and issues to study management teams and business partners
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; review and manage site specific informed consent forms in accordance with SOPs, other procedural documents, and applicable regulations

Skills

GCP

Clinical Trial Management

Study Management Team

Site Selection

Patient Recruitment

Risk Management

Trial Budget Forecasting

Health Authority Inspections

CAPA

SOPs

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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