Job Opportunity: Clinical Trial Project Management Assistant at Lilly

Job Title: Clinical Trial Project Management Assistant

Job Overview: Lilly is seeking a Clinical Trial Project Management Assistant (CTPMA) to provide technical and project administrative support to our Clinical Trial Project Managers (CTPM) and Clinical Development (CD) leadership in Bangalore, Karnataka, India. The role is crucial in ensuring the on-time and on-budget delivery of key tasks during clinical trial execution. The CTPMA will support trial, asset, and portfolio level tasks assigned to specific asset teams or centrally across a Therapeutic Area (TA)/Business Unit (BU).

Key Responsibilities:

Clinical Trial Execution:

• Assist in managing study budgets, including setting up purchase orders and e-requisitions.
• Order, track, and ship study supplies, tools, and instruments.
• Track and report Regional/Global enrollment data for ongoing clinical studies.
• Perform routine study activities following policies and procedures (e.g., Study closeout).
• Participate in shared learning forums.
• Assist with other trial level activities as needed (e.g., coordination of regional and trial project-related meetings, newsletter creation, uploading meeting minutes, etc.).

Clinical Trial/Submission Documentation:

• Collaborate with CTPM and Clinical Development Manager to oversee the maintenance and inspection readiness of study files (e.g., eTMF, study collaboration sites, etc.), including quality reviews and updates.
• Provide support for regulatory and mock inspections.
• Assist in collecting and reviewing key information to support submission activities (e.g., financial disclosures/1572 and OSI).
• Establish, maintain, and use appropriate team information repositories (e.g., Microsoft Teams, eTMF, etc.) and maintain project team rosters.
• Support filing and archiving processes.

Clinical Trial Systems Management:

• Accurately input study timelines and other required trial-level information into the clinical trial database (IMPACT), monitor and update fields as needed, and troubleshoot illogical data.
• Assist in producing and distributing project status reports.
• Coordinate with Clinical Trial Project Managers and Clinical Development Managers to generate various reports such as milestone and budget reports, IMPACT accuracy reports, staff capacity reports, and more.

Minimum Qualification Requirements:

• Two-year degree or 2 years of administrative or technical experience.
• Proficiency in computer usage and experience with various software packages (e.g., Microsoft Word, Excel, PowerPoint, Project).

Highly Desired Skills:

• Strong communication skills, with the ability to communicate clearly and succinctly with team members and leadership.
• Demonstrated ability to work effectively cross-culturally and across regions/geographies with strong customer service skills.
• Strong teamwork and interpersonal skills, including the ability to adapt to changing business needs, attention to detail, self-management, organizational skills, and problem-solving abilities.
• Ability to maintain confidentiality.