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Analyst/Associate- Clinical Trial Coordinator
A career at our company is an ongoing journey of discovery: our 60,300 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.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
About the 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 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:
- Collaborate with clinical teams and provide the support and expertise as subject matter experts to ensure high quality and timely delivery of the clinical studies.
- Collect, review, and perform study data entry into Clinical Trial Management System (CTMS). CTC will either receive data from the company functions (such as Clinical Research Manager or Clinical Trial Leaders) or independently collect data from internal files for data entry. In addition, CTC will review monthly data reports to review data quality, identify inconsistencies, and follow up with the company and CRO (if applicable) clinical teams to resolution.
- Collaborate with clinical team and CRO (if applicable) to create and maintain Trial Team Lists and Vendor Lists to ensure they are always audit inspection ready. CTC will collect data from clinical teams, perform data entry into CTMS, and perform list reconciliations per the agreed timelines.
- Perform compliance submissions into various portals for clinical recruitment material approvals, HCP speaker contracts, etc.
Who You Are:
Graduate background (e.g. Bachelor’s degree) in scientific field plus some to substantial relevant professional experience (2 years or more 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 (minimum 4 years) and/or additional qualifications that also provides exposure to fundamental clinical research related skills & knowledge
- Familiar use of CTMS system
- Excellent oral and written communication in English
- 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 analytical skills
- Ability to streamline and automate processes
- Good computer skills including knowledge of MS Office™ (Word™, Excel™, PowerPoint™), Outlook and TEAMS
- Good administrative, coordination and problem- solving skills
- Good time and priority management, ability to work independently, efficiently under pressure
Job Location- Electronic City Bangalore
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html