Clinical Process Coordinator at IQVIA

Mexico City, Mexico City, Mexico

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

Bachelor's Degree in Life Sciences or other related field (Required)
Knowledge of clinical trials, including clinical trial conduct and applicable regulatory requirements (e.g., ICH, GCP, relevant local laws, regulations, and guidelines)
Typically 0-2 years of prior relevant experience
1 year of relevant clinical research experience with analytical/financial skills, or relevant Project Management experience, or equivalent combination of education, training, and experience
GCP Course (highly valued)
Advanced English level
Excellent Communication and interpersonal skills
Excellent Problem solving and Organization skills
Attention to detail skills

Responsibilities

Lead and oversee the execution of clinical projects and research studies
Provide project-related assistance for all assigned projects, sites, and project teams, ensuring work is conducted in accordance with SOPs, policies, practices, global and local regulations, to meet customer needs and organizational goals
Provide project-related support to project management teams of assigned clinical research studies
Establish and maintain all project documentation; conduct technical reviews and audits of files for accuracy and completion
Track key communications and documents; maintain internal systems and databases
Support in ensuring compliance with contract, SOPs, GCPs, policies, and regulatory requirements
Support in meeting quality and timeline metrics
Assist study manager/study lead in effective management of eTMF and its Inspection Readiness
Establishment and maintenance of Study in Gilead's Global Clinical Trials Management System (GILDA)
Weekly reports and updates, dashboard management
Tracking the subject, site, and visit status and milestones in CTMS/sCTMS
Assist the Study Lead in preparing reports and trackers to track various metrics (electronic data capture report, action items, Protocol deviations etc.)
Perform access management for the study team
Support the clinical project team by accurately updating and maintaining clinical systems within project timelines
Work in partnership with the Study Lead and Study Process Lead (CL) providing support with project management activities to mitigate risk, control cost, manage project schedule, and ensure customer satisfaction related to assigned project/s

Skills

GCP

SOP

eTMF

CTMS

GILDA

dashboard management

access management

clinical trial management

project management

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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