Clinical Operations Specialist

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 activities, enrollment targets, and be 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.
  • Develop and maintain relationships with prioritized institutions and investigators within a specific therapeutic area and in assigned studies.
  • Facilitate investigator site communications, including newsletters and enrollment updates.
  • Support therapeutic area commercial operations 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, including identifying, screening, evaluating, and selecting sites, partnering with quality teams to ensure site qualification for study participation.
  • Coordinate and facilitate study training planning and implementation.
  • Responsible for country-level site activation process, timeline, risk management, contract budget approval, and control.
  • Actively coordinate, participate, and present in audit, inspection, and/or site visit activities as required.
  • Provide input into study-related vendor selection, review, and approval of vendor payments and oversight of vendor deliveries.
  • Coordinate and facilitate enrollment readiness, including local setup activities, CFDA study information online registration, and HGRAO submission in preparation for first patient visit.
  • 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 of monitoring intervals, SDV/SDR backlog, and site compliance.
  • Monitoring oversight, including sampling review, monitoring visit reports, meetings with Study Report Reviewer Specialist, and commercial operations.
  • Oversight of 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 of 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 ensure 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.
  • Responsibilities include understanding and following all compliance, procurement, legal, financial, 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 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 audit, co-monitoring 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.

Lilly 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.

#WeAreLilly

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