Clinical Data Svs Associate

Skill required: Clinical Data Services - Clinical eTMF Management
Designation: Clinical Data Svs Associate
Qualifications:BSc
Years of Experience:1 to 3 years
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.
Clinical Data Services involve the management and processing of data collected during clinical trials. This includes data collection, validation, storage, and analysis to ensure the data is accurate and reliable. The goal is to support clinical research by providing high-quality data that can be used to evaluate the safety and efficacy of medical treatments. These services are essential for regulatory compliance and successful trial outcomes. They often utilize specialized software and systems to manage the data efficiently.
Strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. Includes data review and accuracy checks of trial master file table of contents, head quarters, initial full protocol package and amended FPP checklists, end of trial checklists, essential document reconciliation, and clinical study report appendices.
What are we looking for? •Ability to establish strong client relationship
•Ability to handle disputes
•Ability to manage multiple stakeholders
•Ability to meet deadlines
•Ability to perform under pressure
Roles and Responsibilities: Document Administrators are responsible for carrying out format check of documents requiring compliance for New Drug Application/Marketing Authorization Submission. The format check ensures that the technical quality of submission documents is compliant and meets the document format standards (e.g., PDF property checks, good documentation practice and bookmark/hyperlink checks).

BSc

About Accenture

Accenture is a leading global professional services company that helps the world’s leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services—creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world’s leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities.

Visit us at www.accenture.com 

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