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Associate, Sr. Associate, Manager - Clinical Trial Foundations (P1-3)

3+ years
Not Disclosed
10 March 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Associate, Sr. Associate, Manager - Clinical Trial Foundations (P1-3)
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time, Regular
Job Id: R-82224

Purpose:
Clinical Trial Foundations, part of Clinical Design, Delivery & Analytics (CDDA), leads the strategy and development of clinical trial processes, technologies, and capabilities to accelerate the delivery of medicines globally. The Associate, Sr. Associate, Manager in this domain will serve as the business subject matter expert for systems within clinical development. These roles involve executing business projects, maintaining system capabilities, and collaborating with internal teams and external vendors.

Primary Responsibilities:

1. Clinical Systems and Capability Expertise:

  • Manage clinical technology projects across multiple functions, vendors, and external organizations.

  • Optimize process and technology interfaces across relevant areas.

  • Provide business case analysis when required.

  • Define, measure, and achieve proficiency in new tools/technology and processes.

  • Produce and maintain project documentation, ensuring quality system compliance.

  • Support internal audits and external inspections.

  • Leverage knowledge of technologies to optimize clinical development processes.

  • Follow standardized processes for requirements definition, design, construction, and testing.

  • Implement improvements to reduce cycle time and work effort.

2. Project Management:

  • Resolve operational issues and apply shared learnings across functions and partners.

  • Create best practices to be shared cross-functionally.

  • Perform root cause and impact analyses, applying knowledge to future projects.

  • Collaborate with business and therapeutic areas to deliver the project portfolio.

  • Develop, track, and maintain metrics for the focus area.

  • Partner with LRL Financial and Procurement to manage budgets, invoices, and contracts.

  • Coordinate system testing and create training materials for system releases.

3. Partnership:

  • Identify, monitor, and communicate global customer needs related to processes/technology.

  • Strengthen relationships between key providers and customers within clinical development and IT.

  • Collaborate with vendors to ensure a smooth customer experience.

  • Actively participate in shared learnings across teams.

Minimum Qualification Requirements:

  • Bachelor’s degree OR 3 years of experience in medical, quality, clinical drug development, or clinical information flow with expertise in related processes and evolving technologies.

  • Strong problem-solving, organizational, and process improvement skills.

  • Self-management and initiative to build relationships and learn new business processes.

  • Ability to identify, resolve, or escalate issues proactively.

  • Ability to evaluate and facilitate risk-based decision-making.

Other Information/Additional Preferences:

  • Excellent oral and written communication skills.

  • Project management skills.

  • Technical knowledge to develop study project deliverables (e.g., SAS, XML).

  • Vendor management and oversight skills.

  • Experience with clinical systems and processes.

  • Knowledge of clinical research processes.

Lilly is committed to providing equal opportunities for individuals with disabilities and encourages them to engage in the workforce. If you require accommodations during the application process, please complete the accommodation request form.

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