(Sr.) Manager-Country Study Management
Eli Lilly · Shanghai
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Collaboration and Communication
- Key contact person for CRAs, regional and global team in assigned study
- Develop and maintain relationships with prioritized institutions and investigators within a specific TA and in assigned studies
- Facilitates investigator site communications (e.g., newsletter, enrollment updates)
- Support TA COM on strategic site development and partnerships
- Propose innovative solutions to optimize processes
Business Deliverables
- Accountable for study timeline, quality and budget plan and delivery at country level
- Provide operational strategic input to early protocol development and study timelines
- Lead Country level feasibility
- Lead CRA team to identify, screen, evaluate and select sites partnering with quality team to ensure site qualification for a specific study participation
- Coordinate and facilitate study training planning and implementation
- Responsible for country level site activation process, timeline, risk management, contract budget approval & control
- Actively coordinates, participates and presents in AST, ISST and/or SIVs as required
- Provide input into study related vendors selection, such as vendors for quick start up, recruitment, etc., review and approve vendor payments, oversight vendor deliveries
- Coordinate and facilitate enrollment readiness including all local set-up activities，CFDA study information online registration and HGRAO submission in preparation for FPV
- Lead CRAs to develop enrollment plans ensuring appropriate risk/mitigation at each site in order to meet targets
- Provide input and/or develop and maintain country level monitoring plans as required
- Oversights monitoring intervals, SDV/SDR backlog and site compliances
- Monitoring oversight including sampling review monitoring visit reports, meetings with Study Report Reviewer Specialist and COM
- Oversight site-level data entry and query resolution
- Co-ordinate and conduct study based co-monitoring with CRAs as required
- Accountable for country level Issue Management and Protocol deviation review
- Oversight of study timeline, SDV status and data query resolution as planned
- Verify and approve site payment
- Lead and ensure site self check process within planned time
- Ensure timely closeout site summary and CSR stamping
- Create and maintain Country level system such as eTMF and sCTMS with completeness and high quality
- Oversee site level TMFs to ensure completeness, accuracy and updated in a timely manner
- Collaborate in the preparation of local quality/compliance reviews, internal audits and regulatory inspections and ensures adequate and timely CAPA follow up
- Identify quality issues within the study to implement appropriate corrective action plans or escalate to appropriate level for resolution
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