Flavy MacHado

Clinical Research Professional | TMF & eTMF Specialist | 5+ Yrs in Study Support (Phases I–IV) | Veeva Vault, CTMS, RAVE | Driving Inspection Readiness & Quality Compliance

Role: Clinical Study Associate at Tata Consultancy Services
Location: Mumbai, MH, IN
LinkedIn followers: 500 followers

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About Flavy MacHado

Clinical Study Associate (CSA)- Responsible for providing operational support to the…

Experience

Clinical Study Associate
Tata Consultancy Services
Sep 2019 — Present
Clinical Study Associate (CSA)- Responsible for providing operational support to the Study Management team through all phases of clinical study management in accordance with appropriate quality standards including ICH/GCP and other regulationsHands on experience in eTMF and CTMS system. Managing the set up and maintenance of eTMF and CTMS in accordance with TMF processes (Study, Country and Site artifacts)Hands on experience with systems like CTSP, RAVE, RADA, IXRS and BO Reports. Knowledge on Study Touch-point Environment and vendor systems used for clinical trial studieseTMF Document Specialist (First Level QCier). Completely analyzing the documents, classifying theminto pre- determined sub-classes according to the Regulatory specifications of the Client and FDA.SMT-eTMF Support partner as a dedicated specialist for partnership of Roche study level documents collaboration with TCS.Liaise with project teams for follow-up on documents as well as discrepancy.Indexing of the documents provided by end-users into the eTMF system.Provide support to the Study Management Team in uploading and indexing documents and overall study support which involves direct client interaction.

Contact information

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Current company

Tata Consultancy Services

IT Services and IT Consulting · 726K employees · Founded 1968 · Mumbai, India

Tata Consultancy Services (TCS) is the technology partner of choice for industry leading organizations worldwide. Since its inception in 1968, TCS has upheld the highest standards of innovation, engineering excellence, and customer service. It has set an aspiration to become the world's largest AI-led technology services company and is enabling its clients to transform themselves across the full AI stack, from infrastructure to intelligence. Rooted in the heritage of the Tata Group, TCS is focused on creating long term value for its clients, its investors, its employees, and the community at large. With a highly skilled workforce spread across 55 countries and 202 service delivery centers across the world, the company has been recognized as a top employer in six continents. With the ability to rapidly apply and scale new technologies, the company has built long term partnerships with its clients – helping them emerge as perpetually adaptive enterprises. Many of these relationships have endured into decades and navigated every technology cycle, from mainframes in the 1970s to artificial intelligence today. TCS sponsors 14 of the world’s most prestigious marathons and endurance events, including the TCS New York City Marathon, TCS London Marathon and TCS Sydney Marathon with a focus on promoting health, sustainability, and community empowerment. Caution against fraudulent job offers: TCS doesn’t charge any fee throughout the recruitment process. Refer here: https://www.tcs.com/careers/india/recruitment-fraud-alert

tcs.com

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