Clinical Data Svs Specialist

Designation: Clinical Data Svs Specialist

About Accenture

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

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.

These services are essential for regulatory compliance and successful trial outcomes. They often utilize specialized software and systems to manage the data efficiently.

Provides medical expertise for trial oversight and safety concerns. This includes creation, review and validation of protocol requirement specifications as per the applicable SOP.

• Problem-solving skills
• Written and verbal communication

1. Understand and align work with the strategic direction and team goals defined by senior management
2. Receive guidance on methods and procedures for new assignments while working independently on routine tasks
3. Primary upward interaction is with the direct supervisor, with periodic interaction with clients and Accenture management
4. 5. Make decisions that impact individual deliverables and often influence team outcomes
5. Function as an individual contributor and/or manage small teams or work efforts
6. Work in rotational shifts as required
7. Act as an interface between study teams, offshore teams, and onshore/client stakeholders
8. Collaborate with Senior Statistical Programmers, study leads, and programmers to ensure smooth study execution
9. Perform Quality Control (QC) checks for standard and non standard safety and efficacy deliverables
10. Review approved protocols, study setup documents, submission documents, and output specifications
11. Develop SAS programs and execute standard macros to generate SDTM like datasets, SDTM datasets, Tables, Listings, Figures, and trial specific outputs
12. Perform developer testing and validate datasets and outputs in compliance with defined standards
13. Leverage programming and data standards to maximize efficiency and consistency across studies
14. Maintain project, validation, and programming documentation in accordance with SOP requirements
15. Adhere to all applicable client and Accenture SOPs and quality guidelines
16. Mentor and guide new hires, support onboarding, and address technical or process related queries
17. Conduct and assess Service Readiness Assessments for new resources
18. Support resource management activities for ongoing and upcoming studies
19. Assist Statistical Programming Managers / Service Delivery Leads with operational reporting and daily support
20. Complete assigned trainings within defined timelines and continuously enhance technical skills
21. Support non clinical, organizational, and Business Excellence initiatives and task forces