Clinical Data Svs Specialist

Skill required: Clinical Data Services - Clinical eTMF Management



Designation: Clinical Data Svs Specialist



Qualifications:Bachelor of Pharmacy/Master of Pharmacy



Years of Experience:7 to 11 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 moderately complex problems

May create new solutions, leveraging and, where needed, adapting existing methods and procedures

The person would require understanding of the strategic direction set by senior management as it relates to team goals

Primary upward interaction is with direct supervisor

May interact with peers and/or management levels at a client and/or within Accenture

Guidance would be provided when determining methods and procedures on new assignments

Decisions made by you will often impact the team in which they reside

Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture

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


 
Qualifications 

Bachelor of Pharmacy,Master of Pharmacy