Clinical Data Svs Associate Manager
Designation: Clinical Data Svs Associate Manager
Qualifications:BE/Bachelor of Pharmacy/Master of Pharmacy
Years of Experience:10 to 14 years
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What would you do? You will be aligned with our Life Sciences R&D 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 procedures 2. Understand and align work with the strategic direction and team goals defined by senior management 3. Receive guidance on methods and procedures for new assignments while working independently on routine tasks 4. Primary upward interaction is with the direct supervisor, with periodic interaction with clients and Accenture management 5. Make decisions that impact individual deliverables and often influence team outcomes 6. Function as an individual contributor and/or manage small teams or work efforts 7. Work in rotational shifts as required 8. Act as an interface between study teams, offshore teams, and onshore/client stakeholders 9. Collaborate with Senior Statistical Programmers, study leads, and programmers to ensure smooth study execution 10. Perform Quality Control (QC) checks for standard and non standard safety and efficacy deliverables 11. Review approved protocols, study setup documents, submission documents, and output specifications 12. Develop SAS programs and execute standard macros to generate SDTM like datasets, SDTM datasets, Tables, Listings, Figures, and trial specific outputs 13. Perform developer testing and validate datasets and outputs in compliance with defined standards 14. Leverage programming and data standards to maximize efficiency and consistency across studies 15. Maintain project, validation, and programming documentation in accordance with SOP requirements 16. Adhere to all applicable client and Accenture SOPs and quality guidelines 17. Mentor and guide new hires, support onboarding, and address technical or process related queries 18. Conduct and assess Service Readiness Assessments for new resources 19. Support resource management activities for ongoing and upcoming studies 20. Assist Statistical Programming Managers / Service Delivery Leads with operational reporting and daily support 21. Complete assigned trainings within defined timelines and continuously enhance technical skills 22. Support non clinical, organizational, and Business Excellence initiatives and task forces
Bengaluru
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