Sr. Country Study Manager

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Country Study Management (CSM) is responsible for providing clinical operational expertise to internal and external customers through ownership of country level study operation.The CSM will drive country initiation activities, enrollment targets and be responsible for country level quality oversight and timely delivery of country level study deliverables.The CSM will also contribute ideas to improve processes and manage change while supporting ongoing business objective.

Primary Responsibilities: [Insert core job tasks. See examples below.] 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

Country level contact for Inspection Readiness

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

Facilitate site audit and inspection activities from clinical operation perspective

Maintains familiarity with regulations and guidelines regarding study execution practices

Minimum Qualification Requirements: [List requirements for education, experience, skills and any required certifications. See examples below.]

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

Minimum of 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

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