Centralized Monitoring Asst at IQVIA

Ahmedabad, Gujarat, India

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical Research, HealthcareIndustries

Requirements

Other Graduate/Post Graduate in Life Sciences or educational equivalent
Minimum of 2 years of work experience with minimum 6 months relevant experience, or equivalent combination of education, training and experience (experience level may vary based on customer specific requirements)
Basic knowledge of applicable research and regulatory requirements, i.e. International Conference on Harmonisation - Good Clinical Practice and relevant local laws, regulations, and guidelines
Exposure to Microsoft Applications including but not limited to Microsoft Word, Excel and PowerPoint
Effective written and verbal communication skills including good command of English language
Effective time management skills
Results and detail-oriented approach to work delivery and output
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Strong listening and phone skills
Good data entry skills

Responsibilities

Complete appropriate role-specific training to perform job duties
Under supervision, provide study level administrative support to the clinical study management team (e.g., running system reports, preparing and distributing status reports, creating and maintaining study trackers, follow-up for outstanding issues)
Under supervision, assist in updating and maintaining systems within project timelines/plans and driving tracking compliance in various systems to enable credible data for analysis
Perform the activities as per the task list delegated by CMS leads
Assist CMs in the preparation of i-site pack for their respective sites and countries for assigned studies, by pulling associated reports
Perform assigned access management related administrative tasks to support team members with project execution (e.g., processing access requests, following up with relevant vendors)
Provide support to technical solution specialist (TSS) on formulations in Excel and on the front-end part
Periodic review of site level KRIs and historic site performance according to Central Monitoring Plan
Facilitating early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk
Monitor site performance and make recommendations for timely corrective actions (e.g., Site Telephone Contact or Triggered Onsite Monitoring Visit)
Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed
Review of the Study Central Monitoring Plan
Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested
Adhere to the key activities outlined in the SOW as per customer requirements
Provide project related assistance to assigned project teams
Ensure all work is conducted in accordance with standard operating procedures, policies, good clinical practices and applicable regulatory requirements
Meeting quality and timeline metrics

Skills

Excel

GCP

KRI

Clinical Study Management

Risk Monitoring

Site Performance Analysis

Data Tracking

Access Management

System Reports

Central Monitoring Plan

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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