Clinical Data Svs Sr Analyst
Designation: Clinical Data Svs Sr Analyst
Qualifications:BE/BTech
Years of Experience:5 to 8 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 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
Requesting an Accommodation
Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at 1 (877) 889-9009 or send us an email or speak with your recruiter.
Equal Employment Opportunity Statement
We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.
For details, view a copy of the Accenture Equal Opportunity Statement
Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities.
Accenture is committed to providing veteran employment opportunities to our service men and women.
Other Employment Statements
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States.
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. Further, at Accenture a criminal conviction history is not an absolute bar to employment.
The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information.
California requires additional notifications for applicants and employees. If you are a California resident, live in or plan to work from Los Angeles County upon being hired for this position, please click here for additional important information.
Please read Accenture’s Recruiting and Hiring Statement for more information on how we process your data during the Recruiting and Hiring process.
We work with one shared purpose: to deliver on the promise of technology and human ingenuity. Every day, more than 775,000 of us help our stakeholders continuously reinvent. Together, we drive positive change and deliver value to our clients, partners, shareholders, communities, and each other.
We believe that delivering value requires innovation, and innovation thrives in an inclusive and diverse environment. We actively foster a workplace free from bias, where everyone feels a sense of belonging and is respected and empowered to do their best work.
At Accenture, we see well-being holistically, supporting our people’s physical, mental, and financial health. We also provide opportunities to keep skills relevant through certifications, learning, and diverse work experiences. We’re proud to be consistently recognized as one of the World’s Best Workplaces™.
Join Accenture to work at the heart of change. Visit us at www.accenture.com.