Country Study Manager-DIA
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 35,000 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.
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.
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 CommunicationKey contact person for CRAs, regional and global team in assigned studyDevelop and maintain relationships with prioritized institutions and investigators within a specific TA and in assigned studiesFacilitates investigator site communications (e.g., newsletter, enrollment updates)Support TA COM on strategic site development and partnershipsPropose innovative solutions to optimize processes Business DeliverablesAccountable for study timeline, quality and budget plan and delivery at country level Provide operational strategic input to early protocol development and study timelinesLead Country level feasibilityLead CRA team to identify, screen, evaluate and select sites partnering with quality team to ensure site qualification for a specific study participationCoordinate and facilitate study training planning and implementationResponsible for country level site activation process, timeline, risk management, contract budget approval & controlActively coordinates, participates and presents in AST, ISST and/or SIVs as requiredProvide 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 targetsProvide input and/or develop and maintain country level monitoring plans as requiredOversights monitoring intervals, SDV/SDR backlog and site compliances Monitoring oversight including sampling review monitoring visit reports, meetings with Study Report Reviewer Specialist and COMOversight site-level data entry and query resolutionCo-ordinate and conduct study based co-monitoring with CRAs as requiredAccountable for country level Issue Management and Protocol deviation reviewOversight of study timeline, SDV status and data query resolution as plannedVerify and approve site paymentLead and ensure site self check process within planned timeEnsure timely closeout site summary and CSR stampingCreate and maintain Country level system such as eTMF and sCTMS with completeness and high qualityOversee site level TMFs to ensure completeness, accuracy and updated in a timely mannerCollaborate in the preparation of local quality/compliance reviews, internal audits and regulatory inspections and ensures adequate and timely CAPA follow upIdentify quality issues within the study to implement appropriate corrective action plans or escalate to appropriate level for resolution Regulations and ComplianceResponsible for understanding and complying with all regulatory requirements, ICH/GCP guidelinesResponsibilities include understanding and following all compliance, procurement, legal, financial and Global Medical Standards and ProceduresCoordinate internal process of Anit-Corruption Due Diligence (ACDD) with inverstigatorsResposible for site-level audit and inspection activities from clinical operation perspectiveMaintains familiarity with regulations and guidelines regarding study execution practices
At least Bachelor’s degree or equivalent work experience in a scientific or health-related fieldMinimum of 3-5 years’ CRA or 2 years’ country study manger or similar position working experience in Clinical TrialsFluent English communication in reading, writing and spoken formatsStrong self-management and organization skillsProject management skillsStrong problem solving and communication skills (both verbal and written)Good computer Microsoft office software skillsNeed to travel periodically to ISST, comonitoring activities and potentially other scientific/regional meetingsNeed to have frequent meetings with global team out of working time.Other Information/Additional Preferences:Strong analytical skillsProficiency in use of project management tools such as Excel, MS project, risk assessment and contingency planningStrong leadership and networking skillsStrategic thinkingSelf-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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-21842.
Lilly is an EEO/Affirmative Action 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.
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