Referred By: Niranjan M
Essential Functions
- Complete role-specific training to perform job duties.
- Provide study-level administrative support to the clinical study management team (tasks include running system reports, preparing and distributing status reports, creating and maintaining study trackers, and follow-up on outstanding issues).
- Assist in updating and maintaining systems within project timelines/plans and ensure tracking compliance to enable credible data analysis.
- Perform activities as per the task list delegated by CMS leads.
- Assist CMs in the preparation of i-site packs for their respective sites and countries for assigned studies by pulling associated reports.
- Support access management-related administrative tasks, including processing access requests and following up with relevant vendors.
- Provide support to technical solution specialists (TSS) on formulations in Excel and the front-end part.
- Periodically review site-level KRIs and historic site performance according to the Central Monitoring Plan.
- Facilitate early identification of site-level risk/issues occurring during study conduct and be responsible for risk identification.
- Monitor site performance and recommend timely corrective actions (e.g., Site Telephone Contact or Triggered Onsite Monitoring Visit).
- Review the effectiveness of recommended actions and take appropriate additional actions if no effect is observed.
- Review the Study Central Monitoring Plan.
- Attend Kick-Off meetings, weekly team meetings, and client meetings as needed or requested.
- Adhere to key activities outlined in the SOW as per customer requirements.
Qualifications
- Graduate/Post Graduate in Life Sciences or equivalent education.
- Minimum of 2 years of work experience with at least 6 months of relevant experience, or an equivalent combination of education, training, and experience.
- Basic knowledge of applicable research and regulatory requirements (e.g., International Conference on Harmonisation – Good Clinical Practice and relevant local laws, regulations, and guidelines).
- Proficiency in Microsoft Applications, including but not limited to Word, Excel, and PowerPoint.
- Effective written and verbal communication skills with a good command of the 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.
About IQVIA
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We push the boundaries of human science and data science to make the biggest impact possible – helping our customers create a healthier world. Learn more at IQVIA Careers.
Location: Bengaluru, India
