Clinical Data Management

IQVIA Inc; Thane; On-site; INR 1,800,000 - 2,500,000; Full time

Job summary

IQVIA is seeking an Data Management Lead to manage end-to-end delivery of data management services for single or multi-service projects in India. You will provide leadership for project planning, execution, and close-out, and oversee financial management of data management activities while ensuring quality deliverables on time and within budget.

The role requires 3–4 years of direct Data Management experience including at least 1 year as a CDM project lead, and strong English fluency.

Qualifications

• Bachelor's Degree in health, clinical, biological or mathematical sciences, or related field with proven experience in Data Management.
• 3-4 years direct Data Management experience, including a minimum of 1 year as a CDM project lead.
• English fluency spoken and advanced English.
• Advanced computer applications like Microsoft Excel and Word.
• Should have advanced understanding of Drug development lifecycle and overall clinical research process.

Responsibilities

• Gather Study Setup requirements through discussion with relevant stakeholders.
• With Minimal guidance - support, overview of validation of new Device integrations.
• Oversight & Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor.
• Ensure that all the deliverables are of expected quality standards and meet customer expectations.
• With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/SOW.
• Support Training of New joiners.
• Lead internal study meetings and sponsor audits and participate in Study Kick off meetings and other sponsor meetings.
• Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended as required.
• With Guidance manage & oversight the implementation of new technology / database revisions.
• Work closely with the programming team for process innovation and automation.
• Be compliant to trainings and eSOP reading.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
• Communication with Line Manager, and other team members across functions should be collaborative.
• Perform other duties as directed by Line Manager.

Skills

Data Management

CDM project lead

English fluency

Advanced Excel

Pharma/clinical data

Education

Bachelor's Degree in health, clinical, biological or mathematical sciences

Job description

Job Overview

Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Data Management (DM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; Overview of financial management for data management activities; communications; and milestone deliverables. Perform role of Data Team Lead (DTL).

Essential Functions

• Gather Study Set up requirements through discussion and communication with relevant stakeholders.
• With Minimal guidance - support, overview of validation of new Device integrations.
• Oversight & Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor.
• Ensure that all the deliverables are of expected quality standards and meet customer expectations.
• With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW).
• Support Training of New joiners.
• Lead internal study meetings and internal/ sponsor audits and participate in Study Kick off meetings and other sponsor meetings.
• Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended as required.
• With Guidance manage & oversight the implementation of new technology / database revisions.
• Work closely with the programming team for process innovation and automation.
• Be compliant to trainings and eSOP reading.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
• Communication with Line Manager, and other team members across functions should be collaborative.
• Perform other duties as directed by Line Manager.

Qualifications

• Bachelor's Degree In health, clinical, biological or mathematical sciences, or related field with proven experience in Data Management Req
• 3 -4 years direct Data Management experience, including a minimum of 1 year as a CDM project lead. Pref
• English Fluency Spoken and English Advanced
• Advanced computer applications like Microsoft excel, word, Inbox etc Advanced
• Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.