Job Description

Skill required:

Clinical Data Operations - Clinical Database Testing

Designation:

Clinical Data Svs Associate Manager

Qualifications:

Master Degree in Life Sciences

Years of Experience:

10 to 14 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 699,000 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?

oClinical Data Management oAgile testing oAutomated Testing oClinical External Data Loading oClinical Data Review oAdaptable and flexible oAbility to perform under pressure oProblem-solving skills oAbility to establish strong client relationship oAgility for quick learning

Roles and Responsibilities:

oIn this role you are required to do analysis and solving of moderately complex problems o Typically creates new solutions, leveraging and, where needed, adapting existing methods and procedures o The person requires understanding of the strategic direction set by senior management as it relates to team goals o Primary upward interaction is with direct supervisor or team leads o Generally interacts with peers and/or management levels at a client and/or within Accenture o The person should require minimal guidance when determining methods and procedures on new assignments o Decisions often impact the team in which they reside and occasionally impact other teams o Individual would manage medium-small sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture o Please note that this role may require you to work in rotational shifts




Master Degree in Life Sciences