(Sr.) Manager-Country Study Management

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Job Description of Country Study Manager

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:

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.

Collaboration 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 Anti-Corruption Due Diligence (ACDD) 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 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

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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