Country Study Manager at Eli Lilly and Company

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

At least Bachelor’s degree or equivalent work experience in a scientific or health-related field

Responsibilities

Serve as 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
Facilitate investigator site communications (e.g., newsletter, enrollment updates)
Support TA COM on strategic site development and partnerships
Propose innovative solutions to optimize processes
Be 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
Be responsible for country level site activation process, timeline, risk management, contract budget approval & control
Actively coordinate, participate and present 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
Oversee monitoring intervals, SDV/SDR backlog and site compliances
Perform monitoring oversight including sampling review monitoring visit reports, meetings with Study Report Reviewer Specialist and COM
Oversee site-level data entry and query resolution
Co-ordinate and conduct study based co-monitoring with CRAs as required
Be accountable for country level Issue Management and Protocol deviation review
Oversee 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 ensure 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
Be responsible for understanding and complying with all regulatory requirements, ICH/GCP guidelines
Understand and follow all compliance, procurement, legal, financial and Global Medical Standards and Procedures
Coordinate internal process of Anti-Corruption Due Diligence (ACDD) with investigators
Be responsible for site-level audit and inspection activities from clinical operation perspective
Maintain familiarity with regulations and guidelines regarding study execution practices

Skills

CRA Management

Site Selection

Feasibility Assessment

Study Activation

Budget Management

Risk Management

Vendor Oversight

Protocol Development

Investigator Relations

Enrollment Management

Regulatory Submissions

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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