CLINICAL RESEARCH ASSOCIATE

Company Description
Wisteli has been setup in 2017 and since then has been providing solutions with focus on Artificial Intelligence and Machine Learning.
Wisteli is focused on building industry specific solutions for its clients in US and India. It is developing AI solutions for healthcare, banking and other core industries. It is helping its clients in improving clinical operations, patient care, driving efficiencies and reimagining business
models.
Wisteli uses key AI technologies like Machine Learning, Natural Language Processing (NLP), image processing, speech analytics to extract insights from clinical notes, patient reports, and external information sources to drive business efficiencies.
Wisteli has offices in US and India. It is based out of Noida in India and led by key Industry leaders with significant industry experience in key executive positions.

Do visit www.wisteli.com for more details.
We currently have an opportunity for multiple Clinical Research Associate in our organization in Noida office.

Job Responsibilities:
• 3-5 years of total experience.
• Participate in post-market surveillance activities by leading routine systematic literature reviews (e.g., develop inclusion/exclusion criteria, data extraction plan from included studies, interpret study results, synthesize literature, and prepare summaries into formal reports) for targeted groups or sub-groups.
• Write or edit clinical study documentation, including clinical investigational plans/protocols, Investigator’s Brochures, Periodic reports, Clinical, and Investigational Reports/Clinical Study Reports.
• Critically review and edit scientifically complex documents with substantial intellectual content.
• Analyse available clinical evidence (data from the manufacturer, published literature) to evaluate the safety and performance of any drug, device, or procedure under evaluation.
• Well-developed expertise in market research methodologies or related job experience in the healthcare and life sciences domain.
• Plan, prepare and conduct primary interviews with KOLs and other stakeholders or experts as part of HEOR project execution Confidential
• Develop and execute market access strategies and evidence-generation plans to meet HTA requirements aligned with country objectives
• Ensure high-quality study documentation that is submission-ready for various regulatory agencies and external distribution.
• Strong presentation and written communication skills

Qualification:
• Medical degree – B. Pharma, BHMS/BAMS/BUMS/BPT/MPT/ BSC-Nursing
• MS/M.Sc(Science) Clinical Research