Sr Clinical DB Designer at IQVIA

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceutical, HealthcareIndustries

Requirements

Bachelor's Degree in Science/Computer Science/Information Technology or Bachelor in Technology (Required)
2-4 years of relevant core Technical designer experience and total experience of 7+ years (Required)

Responsibilities

Interpret the study protocol
Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable
Create and update Edit Specification Document
Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page)
Complete the Study Authorization Form and Trial Capacity Request Form (InForm)
Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting; attend and present comments at the Internal Design Review Meeting; may lead Online Screen Review Meeting
Facilitate the internal Edit Specification Review Meeting and lead discussions regarding the Edit Specification Document
Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates
Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan
Escalate potential quality issues
Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures
Review build timelines and provide input as applicable
Review QIP for own projects, identify out of scope activities if any and inform relevant parties
Responsible for multiple study design projects at the same time
Might be working on projects across multiple platforms
Identify areas for process improvements on an ongoing basis; actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes
Responsible for study build & design, edit specifications, system configurations and accountable for associated study design components
Collaborate with various stakeholders including DTL, Programmer, Validation Team, vendors, statisticians, and client representatives
Responsible for the project financials from programming shared services perspective

Skills

Key technologies and capabilities for this role

eCRF designCDMSSDTMCDASHEdit SpecificationsEDCInFormdatabase designLLRRRights and Rolesstudy protocol interpretation

Questions & Answers

Common questions about this position

What qualifications and experience are required for the Sr Clinical DB Designer role?

A Bachelor's Degree in Science, Computer Science, Information Technology, or Technology is required, along with 2-4 years of relevant core Technical designer experience and total experience of 7+ years.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What are the key responsibilities in this role?

The role involves interpreting study protocols, designing and updating eCRF using CDMS tools, creating edit specifications, generating EDC build components, attending various meetings, and managing project financials and risks.

What skills or experience make a strong candidate for this position?

Strong candidates will have experience with eCRF design using CDMS tools aligned with SDTM and CDASH standards, creating edit specifications, leading review meetings, and handling multiple study projects across platforms.

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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