Clinical Data Svs Sr Analyst

Skill required: Clinical Data Services - Medical Monitoring

Designation: Clinical Data Svs Sr Analyst

Qualifications: Any Graduation

Years of Experience: 5- 8 Yrs

What would you do
You will be aligned with our Life Sciences RD 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.Clinical Data Services involve the management and processing of data collected during clinical trials. This includes data collection, validation, storage, and analysis to ensure the data is accurate and reliable. The goal is to support clinical research by providing high-quality data that can be used to evaluate the safety and efficacy of medical treatments. 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.

What are we looking for
Adaptable and flexible

Problem-solving skills

Written and verbal communication

Roles and Responsibilities:
1. Analyze and solve moderately complex problems, including designing solutions by leveraging and adapting existing methods and procedures2. Understand and align work with the strategic direction and team goals defined by senior management3. Receive guidance on methods and procedures for new assignments while working independently on routine tasks4. Primary upward interaction is with the direct supervisor, with periodic interaction with clients and Accenture management5. Make decisions that impact individual deliverables and often influence team outcomes6. Function as an individual contributor and/or manage small teams or work efforts7. Work in rotational shifts as required8. Act as an interface between study teams, offshore teams, and onshore/client stakeholders9. Collaborate with Senior Statistical Programmers, study leads, and programmers to ensure smooth study execution10. Perform Quality Control (QC) checks for standard and non standard safety and efficacy deliverables11. Review approved protocols, study setup documents, submission documents, and output specifications12. Develop SAS programs and execute standard macros to generate SDTM like datasets, SDTM datasets, Tables, Listings, Figures, and trial specific outputs13. Perform developer testing and validate datasets and outputs in compliance with defined standards14. Leverage programming and data standards to maximize efficiency and consistency across studies15. Maintain project, validation, and programming documentation in accordance with SOP requirements16. Adhere to all applicable client and Accenture SOPs and quality guidelines17. Mentor and guide new hires, support onboarding, and address technical or process related queries18. Conduct and assess Service Readiness Assessments for new resources19. Support resource management activities for ongoing and upcoming studies20. Assist Statistical Programming Managers / Service Delivery Leads with operational reporting and daily support21. Complete assigned trainings within defined timelines and continuously enhance technical skills22. Support non clinical, organizational, and Business Excellence initiatives and task forces

Qualification Any Graduation