Clinical Data Services Specialist

Clinical Data Svs Specialist

Skill required: Clinical Data Services - Clinical EDC Build
Designation: Clinical Data Svs Specialist
Qualifications:BE/BTech
Years of Experience:7 to 11 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 784,000 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 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 Programmer : 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 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