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Job Summary
The Trial Capabilities Senior Associate plays a critical role in supporting the efficient planning, execution, and oversight of clinical trials across the Asia Pacific region. This position contributes to ensuring trial readiness, quality, and compliance with regulatory requirements and company standards.
Job Responsibilities
Lead and drive site activation strategy for assigned trials, leveraging historical performance data, country/site insights, and operational experience to optimize timelines and execution.Own end-to-end site activation readiness and progression, ensuring delivery to aggressive study timelines while proactively identifying risks and implementing mitigation strategies independently.Coordinate and oversee site start-up and operational readiness, including:- Setup of site/vendor accounts and system access
- Completion of required site training
- Distribution, shipment tracking, and confirmation of study materials receipt
- Ensuring full site readiness prior to activation
- Manage and maintain trial documentation (e.g., ISF, TMF, essential regulatory documents), including tracking and collection from sites and internal stakeholders to ensure completeness, timeliness, and inspection readiness.
- Utilize Clinical Trial Management Systems (CTMS) (e.g., Veeva Vault or equivalent) and other study systems to track activation progress, manage documentation status, and ensure accurate data entry, reconciliation, and reporting.
- Perform quality control checks on trial documentation and system data to ensure accuracy, completeness, and compliance with ICH-GCP, Lilly SOPs, and applicable regulatory requirements.
- Independently manage operational risks and issues, and proactively escalate critical risks, delays, or concerns with clear articulation of impact and proposed mitigation actions; demonstrates confidence and professionalism in speaking up.
- Collaborate effectively with global study teams and cross-functional partners (e.g., Clinical Operations, Regulatory Affairs, Data Management, etc) to ensure seamless execution of site activation and trial activities.
- Coordinate and support decentralized clinical trial (DCT) activities, including eConsent and digitalization of ICF processes, ensuring alignment with study requirements and local regulatory expectations.
- Act as a subject matter expert (SME) in designated areas, partnering with peers and stakeholders to provide insights, drive alignment, and support decision-making across studies.
- Support audit and inspection readiness, ensuring documentation and system records are complete, compliant, and readily accessible for internal and external reviews.
- Identify and implement process improvements, leveraging data, digital tools, and best practices, while maintaining discipline in adhering to established processes before driving change.
- Provide guidance, training, and mentorship to junior team members to build team capability.
- Stay informed of relevant regulatory requirements and industry best practices, ensuring consistent application in clinical trial execution.
Job Qualifications
- Bachelor's degree in a life science, healthcare, or related field.
- Minimum of 3-5 years of experience in clinical research, preferably within a pharmaceutical, CRO, Life Sciences, Pharmacy or Biomedical degree.
- Demonstrated understanding of clinical trial processes, GCP, and relevant regulatory guidelines.
- Proven track record in budget planning and contract negotiation with investigator sites.
- Experience with Trial Master File (TMF) management and electronic document management systems.
- Strong organizational skills and attention to detail, with the ability to manage multiple priorities effectively in a fast-paced environment.
- Ability to work collaboratively within cross-functional teams while maintaining accountability for assigned deliverables.
- Proactive, self-motivated, and demonstrates a strong sense of ownership.
- Highly agile with a positive mindset toward change, demonstrating openness and adaptability in evolving operational and digital environments.
- Process improvement mindset, with the ability to identify optimization opportunities while maintaining discipline to fully understand and execute existing processes before proposing enhancements.
- Digital and AI literacy (basic to intermediate), with hands-on experience or demonstrated interest in applying AI tools (e.g., Copilot, Claude, Gemini) to improve productivity and operational efficiency considered a strong advantage.
- Excellent written and verbal communication skills in English.
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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