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Job Information

Lilly Country Study Manager in 上海, China

Job Category:

医学

Type of Employment:

全职员工

Responsibilities:

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.

Collarboration 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

Regulations and Compliance

Responsible for understanding and complying with all regulatory requirements, ICH/GCP guidelines

Responsibilities include understanding and following all compliance, procurement, legal, financial and Global Medical Standards and Procedures

Coordinate internal process of Anit-Corruption Due Diligence (ACDD) with inverstigators

Resposible for site-level audit and inspection activities from clinical operation perspective

Maintains familiarity with regulations and guidelines regarding study execution practices

Basic Qualificiations:

Minimum Qualification Requirements:

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

Minimum of 3-5 years’ CRA or 2 years’ country study manger or similar position working experience in Clinical Trials

Fluent English communication in reading, writing and spoken formats

Strong self-management and organization skills

Project management skills

Strong problem solving and communication skills (both verbal and written)

Good computer Microsoft office software skills

Need to travel periodically to ISST, comonitoring activities and potentially other scientific/regional meetings

Need to have frequent meetings with global team out of working time.

Other Information/Additional Preferences:

Strong analytical skills

Proficiency in use of project management tools such as Excel, MS project, risk assessment and contingency planning

Strong leadership and networking skills

Strategic thinking

Self-motivated and with good teamwork spirit

Additional Skills/Preferences:

Additional Information:

Company Overview:

Posted Date:

Keyword:

Region: 亚洲/太平洋地区

City: 上海

State: 上海市

Country: CHN

Location Details:

Req Id: 51917BR

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