Senior Clinical Data Services Analyst

Clinical Data Svs Sr Analyst

Skill required: Clinical Data Operations - Clinical Database Testing
Designation: Clinical Data Svs Sr Analyst
Qualifications:Bachelor Degree in Life Sciences/Master Degree in Life Sciences
Years of Experience:5 to 8 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 and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements. Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. Experience with Clinical testing - Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP.
What are we looking for? •Ability to establish strong client relationship •Ability to manage multiple stakeholders •Ability to meet deadlines •Ability to perform under pressure •Ability to work well in a team Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP.
Roles and Responsibilities: •In this role you are required to do analysis and solving of increasingly complex problems • Your day to day interactions are with peers within Accenture • You are likely to have some interaction with clients and/or Accenture management • You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments • Decisions that are made by you impact your own work and may impact the work of others • In this role you would be an individual contributor and/or oversee a small work effort and/or team • Please note that this role may require you to work in rotational shifts