Senior Manager - Country Study Management

3-5 years

Not Disclosed

Shanghai Shi

10 Jan. 31, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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

Job Title: Senior Manager - Country Study Management
Location: Shanghai, Shanghai, China
Category: Research & Development
Job Type: Full Time, Regular
Job ID: R-78168

Company Overview:

At Eli Lilly, we unite caring with discovery to improve lives globally. As a leading healthcare company headquartered in Indianapolis, Indiana, our mission is to innovate and deliver life-changing medicines. We focus on advancing disease management and treatment while actively engaging with our communities through philanthropy and volunteerism. Join our team of dedicated professionals working toward a better tomorrow.

Position Overview:

The Senior Manager - Country Study Management is a key role responsible for overseeing and managing clinical studies at the country level in China. This individual will act as a central point of contact for both internal teams and external stakeholders, ensuring the successful initiation, execution, and closure of studies. This position involves close collaboration with government bodies, hospitals, clinical research associates (CRAs), and cross-functional global teams, with a focus on improving clinical development efficiency and study timelines.

Key Responsibilities:

Collaboration and Communication:

Serve as the key contact for the MIC project team, collaborating with Beijing government and hospitals to enhance clinical development efficiency.
Maintain effective communication with CRAs, the regional, and global teams in assigned studies.
Build and maintain relationships with prioritized institutions and investigators for specific therapeutic areas (TAs) and assigned studies.
Facilitate investigator site communications (e.g., newsletters, enrollment updates).
Support the TA COM in strategic site development and partnerships.
Propose and implement innovative solutions to optimize study processes.

Business Deliverables:

Accelerate site initiation for two pilot Beijing sites, aiming to meet the initiation speed targets set by the Beijing government for 2025.
Apply learnings from pilot sites to improve initiation speed at other Beijing sites in subsequent years, ultimately aligning with Lilly’s average initiation speed across all sites.
Be accountable for study timelines, quality, budget plans, and delivery at the country level.
Provide operational strategic input to early protocol development and study timelines.
Lead country-level feasibility studies and collaborate with global teams to ensure efficient site selection.
Lead the CRA team to identify, evaluate, and select study sites, partnering with quality teams to ensure proper site qualification.
Coordinate study training planning and ensure effective training implementation.
Oversee the country-level site activation process, including timelines, risk management, contract budget approval, and control.
Actively participate in AST, ISST, and SIVs as required.
Provide input into vendor selection and manage relationships with vendors for start-up, recruitment, and other needs.
Coordinate and facilitate enrollment readiness, including CFDA study registration and HGRAO submissions in preparation for FPV.
Lead CRAs in the development of enrollment plans, ensuring risk mitigation at each site to meet enrollment targets.
Develop and maintain country-level monitoring plans, ensuring compliance with study requirements.
Oversee monitoring intervals, SDV/SDR backlog, and site compliance.
Ensure timely resolution of data queries and manage site-level TMFs for completeness, accuracy, and timeliness.
Ensure proper closeout procedures, including site summary and CSR stamping.

Regulations and Compliance:

Ensure compliance with all regulatory requirements, ICH/GCP guidelines, and company standards.
Coordinate Anti-Corruption Due Diligence (ACDD) processes with investigators.
Participate in site-level audit and inspection activities and ensure proper CAPA follow-up.
Stay updated on all regulations regarding study execution and apply them effectively in the country.

Quality and Issue Management:

Collaborate in the preparation for local quality reviews, internal audits, and regulatory inspections.
Identify quality issues during the study and implement appropriate corrective actions.
Oversee study issue management and ensure protocol deviations are addressed promptly.

Minimum Qualifications:

Bachelor’s degree (or equivalent experience) in a scientific or health-related field.
A minimum of 3-5 years of experience as a CRA or 2 years in a country study manager role, or similar experience in clinical trials.
Fluency in English, with strong reading, writing, and verbal communication skills.
Excellent self-management and organizational skills.
Proficient in project management with the ability to manage complex timelines and deliverables.
Strong problem-solving and communication skills.
Proficient in using Microsoft Office software.
Ability to travel periodically to study sites, co-monitoring activities, and regional meetings.
Availability for frequent meetings with the global team outside of regular working hours.
Strong interpersonal skills with the ability to collaborate effectively with multiple stakeholders, including the MIC project team, hospital leadership, and government staff.

Preferred Qualifications:

Previous Site Operational Excellence experience.
Strong analytical and strategic thinking abilities.
Proficiency in project management tools like Excel, MS Project, and experience with risk assessment and contingency planning.
Leadership and networking skills.
Self-motivated with a strong teamwork spirit.

Additional Information:

Travel Requirements: Periodic travel for ISST meetings, co-monitoring activities, and other scientific/regional meetings.
Working Hours: Must be flexible to accommodate meetings with the global team outside regular working hours.

Benefits:

Eli Lilly offers a comprehensive benefits package that includes eligibility for a company-sponsored 401(k), pension, health benefits, flexible spending accounts, life insurance, wellness programs, and more.

EEO Statement:

Lilly is an Equal Employment Opportunity/Affirmative Action Employer. We do 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.

How to Apply:

If you need accommodations to submit a resume for this position, please complete the accommodation request form available on our careers page. For more information about #WeAreLilly and our commitment to diversity and inclusion, please visit our website.

This position offers an exciting opportunity for a Senior Manager to lead clinical study management efforts at the country level in China while driving efficiency and innovation in the clinical development process at Eli Lilly.

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