Country Study Manager

1 month ago

Shanghai, Shanghai, China Lilly Full time
Job Description

We are seeking a highly skilled and experienced Country Study Manager to join our team at Lilly.

The successful candidate will be responsible for providing clinical operational expertise to internal and external customers through ownership of country-level study operations.

Key Responsibilities:

  • Drive country initiation activities and enrollment targets
  • Responsible for country-level quality oversight and timely delivery of country-level study deliverables
  • Contribute ideas to improve processes and manage change while supporting ongoing business objectives
  • Collaborate with CRAs, regional and global teams in assigned studies
  • Develop and maintain relationships with prioritized institutions and investigators within a specific therapeutic area
  • Facilitate investigator site communications and support TA COM on strategic site development and partnerships
  • Propose innovative solutions to optimize processes
  • 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 and site activation processes
  • Coordinate and facilitate study training planning and implementation
  • Responsible for country-level site activation, risk management, contract budget approval, and control
  • Actively coordinate, participate, and present in AST, ISST, and/or SIVs as required
  • Provide input into study-related vendors selection, review, and approval
  • Coordinate and facilitate enrollment readiness, including local set-up activities, CFDA study information online registration, and HGRAO submission
  • Lead CRAs to develop enrollment plans ensuring appropriate risk mitigation at each site to meet targets
  • Provide input and/or develop and maintain country-level monitoring plans as required
  • Oversight monitoring intervals, SDV/SDR backlog, and site compliance
  • Monitoring oversight, including sampling review, monitoring visit reports, meetings with Study Report Reviewer Specialist, and COM
  • Oversight site-level data entry and query resolution
  • Coordinate 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 systems, such as eTMF and sCTMS, with completeness and high quality
  • Oversight site-level TMFs to ensure completeness, accuracy, and update 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 the appropriate level for resolution
  • Responsible for understanding and complying with all regulatory requirements, ICH/GCP guidelines, and Global Medical Standards and Procedures
  • Coordinate internal process of Anti-Corruption Due Diligence with investigators
  • Responsible for site-level audit and inspection activities from a clinical operation perspective
  • Maintains familiarity with regulations and guidelines regarding study execution practices

BASIC QUALIFICATIONS:

  • 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 manager 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, co-monitoring activities, and potentially other scientific/regional meetings
  • Need to have frequent meetings with global teams 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

Lilly is an equal opportunity employer and 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.

  • Country Study Manager

    2 months ago

    Shanghai, Shanghai, China Lilly Full time

    Job Summary:Lilly is seeking a highly skilled and experienced Country Study Manager to join our team. As a key member of our clinical operations team, you will be responsible for providing clinical operational expertise to internal and external customers through ownership of country-level study operations.Key Responsibilities:Drive country initiation...

  • Country Study Manager

    2 weeks ago

    Shanghai, Shanghai, China Lilly Full time

    We're seeking a highly skilled Country Study Manager to join our team at Lilly. As a key member of our clinical operations team, you will be responsible for providing clinical operational expertise to internal and external customers through ownership of country-level study operations.Key Responsibilities:Drive country initiation activities and enrollment...

  • Country Study Management Lead

    2 months ago

    Shanghai, Shanghai, China Lilly Full time

    We're seeking a highly skilled and experienced Country Study Management professional to join our team at Lilly.About the Role:The Country Study Management (CSM) is a critical role that requires strong clinical operational expertise to drive country-level study operations. As a CSM, you will be responsible for providing clinical operational expertise to...

  • Country Study Management Lead

    1 day ago

    Shanghai, Shanghai, China Lilly Full time

    We are seeking a highly skilled Country Study Management Lead to join our team at Lilly. This role is responsible for providing clinical operational expertise to internal and external customers through ownership of country-level study operations.Key Responsibilities:Drive country initiation activities and enrollment targetsEnsure country-level quality...

  • Country Manager

    3 weeks ago

    Shanghai, Shanghai, China Pacific Biosciences Full time

    Country Manager - ChinaPacific Biosciences is a leading life science technology company that designs, develops, and manufactures advanced sequencing solutions to help scientists and clinical researchers resolve complex biological problems. Our mission is to enable the promise of genomics to improve human health. Genomics is at the heart of all biological...

  • Country Manager

    4 weeks ago

    Shanghai, Shanghai, China Pacific Biosciences Full time

    Country Manager - ChinaPacific Biosciences is a leading life science technology company that designs, develops, and manufactures advanced sequencing solutions to help scientists and clinical researchers resolve complex biological problems. Our mission is to enable the promise of genomics to improve human health. Genomics is at the heart of all biological...

  • Global Study Coordinator

    2 months ago

    Shanghai, Shanghai, China Lilly Full time

    Job Summary:Lilly is seeking a highly skilled and experienced Country Study Manager to join our team. As a key member of our clinical operations team, you will be responsible for providing clinical operational expertise to internal and external customers through ownership of country-level study operations.Key Responsibilities:Drive country initiation...

  • Operations Manager

    1 month ago

    Shanghai, Shanghai, China Study Group Full time

    Transformative Opportunity in Global EducationEmbark on a dynamic journey with Study Group, a pioneering leader in international education. As our Operations Manager, you will play a pivotal role in shaping the future of global education by optimizing operational processes for our existing business partnerships across the Rest of World (RoW) regions.Key...

  • Study Operations Manager

    1 week ago

    Shanghai, Shanghai, China AbbVie Full time

    Job SummaryWe are seeking a highly skilled and experienced Study Operations Manager to join our team at AbbVie. As a Study Operations Manager, you will be responsible for delivering best-in-class study execution, driving financial and headcount efficiencies, and increasing flexibility to rapidly respond to shifting business needs.Key ResponsibilitiesPartner...

  • Study Operations Manager

    4 weeks ago

    Shanghai, Shanghai, China AbbVie Full time

    Job SummaryWe are seeking a highly skilled and experienced Study Operations Manager to join our team at AbbVie. As a key member of our Study Management organization, you will be responsible for delivering best-in-class study execution, driving financial and headcount efficiencies, and increasing flexibility to rapidly respond to shifting business needs.Key...

  • Operations Manager

    2 weeks ago

    Shanghai, Shanghai, China Study Group Full time

    Transformative Opportunity:Embark on a journey with Study Group, a global leader in international education, to empower students worldwide to unlock their full potential. As our Operations Manager, you will optimize operational processes for existing business partnerships across the Rest of World (RoW) regions, providing effective advice, guidance, and...

  • Study Management Associate III

    1 day ago

    Shanghai, Shanghai, China AbbVie Full time

    Job DescriptionSupporting the Study Project ManagerIn this role, you will support the Study Project Manager in leading a cross-functional team through stakeholder engagement and influence to drive deliverables and timelines for global trials. This includes study-level oversight and leadership of assigned activities from inception through closure.Vendor...

  • Associate, Study Management Specialist

    3 weeks ago

    Shanghai, Shanghai, China AbbVie Full time

    Job SummaryWe are seeking a highly skilled Associate, Study Management III to join our team at AbbVie. In this role, you will provide strategic leadership and support to the Study Project Manager in driving deliverables and timelines for global trials. Your expertise in vendor management, recruitment, and risk identification will be invaluable in ensuring...

  • Senior Study Operations Manager

    2 weeks ago

    Shanghai, Shanghai, China AbbVie Full time

    Job SummaryWe are seeking a highly skilled Senior Study Operations Manager to join our team at AbbVie. In this role, you will be responsible for delivering best-in-class study execution, driving financial and headcount efficiencies, and increasing flexibility to rapidly respond to shifting business needs.Key ResponsibilitiesPartner with study teams to drive...

  • Global Education Operations Director

    2 days ago

    Shanghai, Shanghai, China Study Group Full time

    Transformative Journey with Study GroupEmbark on a groundbreaking career path with Study Group, a pioneering leader in global education. We empower students worldwide to unlock their full potential through innovative pathways to higher education, forged in collaboration with prestigious universities and institutions.Operations Manager RoleJoin our dynamic...

  • Clinical Study Manager

    2 weeks ago

    Shanghai, Shanghai, China Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch Full time

    Job SummaryWe are seeking a highly skilled and experienced Clinical Study Manager to join our team at Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch. The successful candidate will be responsible for managing clinical studies from start to finish, ensuring timely and successful completion of projects.Key ResponsibilitiesDevelop and execute...

  • Clinical Study Manager

    2 months ago

    Shanghai, Shanghai, China Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch Full time

    Job SummaryWe are seeking a highly skilled Clinical Study Manager to join our team at Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch. As a Clinical Study Manager, you will be responsible for the day-to-day management of one or more clinical studies, ensuring that assigned studies are conducted in accordance with GCPs, Local regulations and...

  • Clinical Study Manager

    2 months ago

    Shanghai, Shanghai, China Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch Full time

    Job SummaryWe are seeking a highly skilled Clinical Study Manager to join our team at Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch. The successful candidate will be responsible for the day-to-day management of one or more clinical studies, ensuring that assigned studies are conducted in accordance with Good Clinical Practices (GCPs), local...

  • Clinical Study Manager

    2 days ago

    Shanghai, Shanghai, China Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch Full time

    Job Summary:As a Clinical Study Manager at Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch, you will play a key role in the successful execution of clinical studies. Your primary responsibility will be to develop and execute clinical project plans, ensuring timely completion and within budget. You will lead a team of clinical staff, providing...

  • Study Operations Manager

    4 weeks ago

    Shanghai, Shanghai, China AbbVie Full time

    Job Title: Study Operations ManagerDelivering on best-in-class study execution, while driving financial/headcount efficiencies, and increasing flexibility to rapidly respond to shifting business needs. Partnering with study teams to drive the implementation of aggressive execution strategies in challenging spaces such as Enterprise Critical programs,...