Clinical Data Svs Analyst

Skill required: Clinical Data Services - Clinical eTMF Management

Designation: Clinical Data Svs Analyst

Qualifications:Bachelor of Pharmacy/Master of Pharmacy

Years of Experience:3 to 5 years


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.
The Clinical Data Management team focuses on the collection, integration, and 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. They help 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 team also managing clinical data management projects.
You will be expected to use 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?

Clinical eTMF Management

Adaptable and flexible

Ability to perform under pressure

Problem-solving skills

Detail orientation

Ability to establish strong client relationship
Roles and Responsibilities:

In this role you are required to do analysis and solving of lower-complexity problems

Your day to day interaction is with peers within Accenture before updating supervisors

In this role you may have limited exposure with clients and/or Accenture management

You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments

The decisions you make impact your own work and may impact the work of others

You will be an individual contributor as a part of a team, with a focused scope of work

Please note that this role may require you to work in rotational shifts

Qualifications
Bachelor of Pharmacy,Master of Pharmacy