Clinical Data Svs Sr Analyst
Designation: Clinical Data Svs Sr Analyst
Qualifications:BE/BTech
Years of Experience:5 to 8 years
About Accenture
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What would you do? You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience. eCOA Programmers: Build, configure, validate, and maintain eCOA/ePRO/eDiary solutions used in clinical trials to capture patient-, clinician-, and observer-reported outcomes. The role ensures platforms are accurately configured to protocol, compliant with GxP, 21 CFR Part 11, and data privacy requirements, while delivering high-quality, on-time releases across studies and geographies. Core Responsibilities · Translate protocol and Schedule of Assessments (SoA) into eCOA specifications (visit schedules, windows, reminders, edit checks, branching logic). · Configure forms, questionnaires (e.g., PROs, ClinROs, ObsROs), visit calendars, alerts, device provisioning flows, and study metadata in eCOA platforms. · Build edit checks, derivations, and rules (e.g., compliance logic, skip/branching, conditional displays). · Set up data export mappings to EDC/CTMS/biostats pipelines (e.g., SDTM/ADaM alignment, ODM/XML, JSON, SFTP). · Collaborate with data management on CRF harmonization and reconciliation rules (e.g., eCOA vs EDC discrepancies). · Support wearables/IoT integrations where applicable (e.g., actigraphy devices, BP cuffs). · Ensure compliance with 21 CFR Part 11, Annex 11, GxP, GDPR/CCPA, and sponsor SOPs.
What are we looking for? •Adaptable and flexible •Ability to perform under pressure •Problem-solving skills •Ability to establish strong client relationship •Agility for quick learning Required Skill Set · Strong understanding of clinical trial lifecycle, SoA, endpoints, PRO/ClinRO/ObsRO concepts. · Knowledge of GxP and validation practices: GAMP 5, CSV, 21 CFR Part 11, Annex 11. · Platform Expertise - Signant Health (CRF Health/eCOA), Medidata Patient Cloud, IQVIA eCOA, ERT/Clario, YPrime, Oracle/ObvioHealth/ePRO platforms, TrialMax, TrialKit, uMotif, or similar. · Configurations: forms, schedules, edit checks, rules engines, device provisioning, notifications, translations, roles/permissions.
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
Bengaluru
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