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Senior Clinical Trial Coordinator

4.00 to 9.00 Years   Mumbai City   23 Jun, 2021
Merck Ltd
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.Position Title - Senior Clinical Trial CoordinatorJob Location- Electronic City Bangalore Your role: an exciting opportunity has arisen to join our healthcare business to support the development of first and best in class specialty medicines for our patients in need. You would work in a new established group, that provides a shared service center support for study teams of Phase I - Phase IV (interventional & non-interventional) and Investigator Sponsored Studies with and without CRO involvement. As a Clinical Trial Coordinator, you will manage activities within a dedicated Center of Excellence for operational deliverables of Clinical Studies with interactions of multiple cross functional Biopharma functions and CROs. Your main responsibilities would be:

  • Conduct Trial Master File Oversight and Archiving Management
  • Perform Operational data entry & oversight in systems
  • Perform Purchase Orders / Invoice Mangament and Payments tracking
  • Responsible to manage Clinical Site and Investigator Sponsored Studies (ISS) agreements
  • Prepare EC/ IRB submission package for study teams, if no CRO involved
  • Request and oversee Study Insurance Coordination
  • Support Inspection Preparation & Inspection Readiness related activities
  • Conduct CAPA and SUSAR tracking
  • Provide regional Dashboards, Data Driven Oversight (DDO) reports & site individual packages
  • Responsible for study key deliverables tracking
  • Perform Safety listings tracking and Safety Check Desk tasks
Who You Are:
  • Graduate background (e.g. Bachelor s degree) in scientific field plus some to substantial relevant professional experience (four years in Clinical Development or equivalent) and good knowledge and experience in own discipline and beyond
  • Non- graduated jobholders require a substantial amount of professional experience in a clinical research-related position (six years or equivalent) and/ or additional qualifications that also provides exposure to fundamental clinical research related skills & knowledge
  • Excellent oral and written communication in English
  • Ability to mentor and coach junior or new staff
  • Professional Trial Master File Experience, including use of different eTMF Systems
  • Experience to use the DIA TMF Reference Model as TMF Filing Index
  • Professional experience with use of CTMS System
  • Ability to work in an international/ multicultural cross functional matrix environment
  • Good understanding of the policies and procedures of Clinical Operations and of ICH-GCP
  • Good administrative, coordination and problem- solving skills
  • Good time and priority management, ability to work efficiently under pressure
  • Strong computer skills including knowledge of MS Office (Excel , Word , PowerPoint ), Outlook and TEAMS
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!Curious Apply and find more information at https://jobs.vibrantm.com,

Keyskills :
clinical researchclinical trialsdata collectionaccountabilityannual reportscenter of excellenceshared service centerphase ims officedata entrycomputer skillspurchase ordersclinical operationsstatements of work sow

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