Job Description

Skill required: Data Maintenance - Clinical Data Management (CDM)

Designation: Associate

Job Location: Bengaluru

Qualifications: MSc/Master of Pharmacy

Years of Experience: 1-3 years

About Accenture

Accenture is a leading global professional services company, providing a broad range of services in strategy and consulting, interactive, technology and operations, with digital capabilities across all of these services. We combine unmatched experience and specialized capabilities across more than 40 industries - powered by the world's largest network of Advanced Technology and Intelligent Operations centers. With 513,000 people serving clients in more than 120 countries, Accenture brings continuous innovation to help clients improve their performance and create lasting value across their enterprises. Visit us at www.accenture.com

  

What would you do?

You will be aligned with our Pharmaceuticals Processes vertical and help us with the processes to collect, monitor, research, assess and evaluate information on the adverse effects of medication with a view to identifying new information about hazards associated with medicines and consequently, prevent harm to patients. It also deals with the reviewing and resolving of discrepancies identified by the system or through manual checks as per guidelines. Employees under this span can also be responsible for a number of activities related to the design, development, and maintenance of Clinical Database objects.

You will be working as a part of the Data Maintenance team which is responsible for completeness & validity of the data in the clinical database. The team reviews and resolves discrepancies identified by the system or through manual checks as per guidelines, issue data clarification forms as and when required. You will have to perform discrepancy review & perform Self-Evident Corrections per DRP (as and when required). You will also solve for discrepancy management for SAE related discrepancies.

The Clinical Data Management focuses on the collection, integration and the availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts and carry-out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects.

Roles and Responsibilities

  • In this role you are required to solve routine problems, largely through precedent and referral to general guidelines
  • Your expected interactions are within your own team and direct supervisor
  • You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments
  • The decisions that you make would impact your own work
  • You will be an individual contributor as a part of a team, with a predetermined, focused scope of work
  • Please note that this role may require you to work in rotational shifts.

What are we looking for?

We are looking for individuals who have the following skillset:

  • Interpersonal skills
  • Time Management
  • Active Listening
  • Project Management
  • Analytic skills

It would be a value add if you are proficient in:

  • Pharma Elec Data Capture (EDC)
  • Pharmaceutical Drug Safety Surveillance


Qualifications

MSc/Master of Pharmacy

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Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.

Accenture is committed to providing veteran employment opportunities to our service men and women.

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