Job title: Unblinded Clinical Lead Role

Company: IQVIA

Job description: JOB DESCRIPTION Job Overview: Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Clinical Lead is a member of the core project t

JOB DESCRIPTION Job Overview: Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Clinical Lead is a member of the core project team responsible for the clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Clinical Leads ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams ensuring projects meet delivery requirements at all times. 1. Leads and coordinates the monitoring activities from site activation through to study closure at country level in accordance with the Monitoring Plans 2. Acts as primary point of contact for CRAs for questions/ issues/ risks/ concerns/ doubts on a daily basis 3. Prepare and conduct trainings for study team 4. Participates in training and coaching new members of the team, ensuring compliance with ICH-GCP and Sponsor Documents 5. Training on updates to blinding processes, management and communication following new versions of study documents 6. Tracking the evidence of training for CRAs 7. Supports CRAs in issue management 8. Develop SVR annotations and review SVRs 9. Escalates relevant issues to the Global Study Team (GST) members 10. Assist CRA in preparation for site/in-house audits 11. Final eTMF review and reconciliation 12. Updates Line Managers of CRAs about their performance and escalate if needed. 13. Assists with CAPAs, as a result of thorough root cause analysis 14. Attends study meetings, if needed: Related to Vendors and Study Team Global/ Local 15. Reports study progress updates to the Global Study Leader/ Global Study Team 16. Participate in document management (creation, review, maintenance, storage, as applicable) 17. Coordinate and collaborate with various project stake holders. 18. Review, evaluate and recommend modifications to designated processes 19. Collaborate with the project lead/team members in creation/review of study documents 20. Plans and leads activities associated with audits and regulatory inspections in liaison with CQM and QA with regards to the unblinded part of the study Qualifications . Bachelor’s Degree Bachelor’s Degree in health care or other scientific discipline required Req . Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience. . Requires basic knowledge of Project management practices and terminology. . Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. . Requires broad protocol knowledge and therapeutic knowledge. . Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates. . Requires understanding of project finances. . Knowledge of clinical trials – Knowledge of clinical trial conduct in addition to skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct. Skills: . Communication – Strong written and verbal communication skills including good command of English language. . Problem solving – Problem solving skills. . Organization – Planning, time management and prioritization skills. . Prioritization – Ability to handle conflicting priorities. . Quality – Attention to detail and accuracy in work. Results-oriented approach to work delivery and output. . Leadership – Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues. . IT skills – Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint. . Collaboration – Ability to establish and maintain effective working relationships with coworkers, managers and clients. . Cross-collaboration – Ability to work across geographies displaying high awareness and understanding of cultural differences. . Effective communication – Ability to influence without authority. IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

Expected salary:

Location: Thane, Maharashtra

Job date: Sat, 23 Jul 2022 22:10:53 GMT

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