Sr Lab Set up Coordinator

IQVIA; Thane, Bengaluru; On-site; INR 420,000 - 660,000; Full time

Job summary

IQVIA in India is seeking a Sr Lab Project Set-Up Coordinator to support the design, loading, and validation of Lab databases using Clinical Trials Management Systems, ensuring adherence to SOPs and good practice. You will own the quality of database configuration and collaborate with study teams and sponsors.

The role emphasizes strong organizational skills, coordination across departments, and participation in audits and process improvements, aligned with regulatory standards.

Qualifications

• Minimum 1 year experience in Clinical/Medical/Healthcare field.
• Experience with lab data/configuration preferred.
• Strong organizational and coordination skills.

Responsibilities

• Assist with study validation activities
• Research problems, gather information, and liaise with lab colleagues to ensure projects follow procedures and customer requirements
• Configure project database where applicable
• Maintain accurate project documentation files
• Keep Setup Managers and Project Managers informed of issues affecting project
• Coordinate meetings with relevant colleagues and internal departments
• Participate in local and global improvement projects as defined by process teams
• Participate in internal audits, as required
• Communicate with study Sponsor(s) as needed
• Assist in development of database design requirements for protocols and amendments
• Contribute to project planning, timelines, and regulatory steps
• Manage setup for low complexity studies; mentor junior staff
• Work per ICH E6 Guideline for Good Clinical Practice.

Skills

Lab operations

Data management

Attention to detail

English comms

Project coordination

Education

Bachelor’s in Life Sciences

High School Diploma

Tools

CTMS

Excel

Docs management

Job description

Role & responsibilities

Sr Lab Project Set-Up Coordinator

Preferred candidate profile

3 years to 4 years of relevant experience, with preference for exposure to laboratory operations, data management, or database configuration.

Job Description Summary

Provide project related support; assist with designing, loading, and validation of Lab databases using Clinical Trials Management System(s); ensure work is conducted in line with standard operating procedures, policies and good practice. Accountability and ownership for the quality of database configuration.

Essential Functions

• Assist with study validation activities
• Research problems, gather information, and liaise with lab colleagues to help ensure projects are set-up in line with established procedures and customer requirements
• Configure project database, where applicable
• Maintain accurate project documentation files
• Keep Setup Managers, Project Managers and other relevant staff informed of any issues that may affect the smooth running of the project
• Coordinate meetings with relevant colleagues and internal departments (e.g. planning and handover meetings)
• Participate in local and global improvement projects as defined by the relevant process improvement management team
• Participate in internal audits, as required
• Communicate with study Sponsor(s) as needed (e.g. exchanging factual information)
• Assist in the development of database design requirements for protocols and protocol amendments
• Contribute to project planning, such as creating accurate project timelines, complying with regulatory steps, and identifying potential project related issues
• Manage the set-up process for a low complexity study, where applicable. Mentor and assist in training more junior staff
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

Qualifications

• High School Diploma or equivalent Req And
• Bachelor's Degree Life Sciences or related field Pref
• Minimum 1 year relevant experience in the Clinical, Medical or Healthcare industry.
• r equivalent combination of education, training and experience.
• Posses strong organizational and coordination skills.
• Proven track record of quality, accuracy and attention to detail.
• Good written and verbal communication skills including good command of English language.
• Computer proficiency in word processing and spreadsheet applications.
• Posses enhanced technical and operational knowledge, especially in the area of Clinical Trial Management Systems (preferred).
• Demonstrated ability to work in a fast-paced environment.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Knowledge of Laboratory processes and computer systems helpful.