Lilly Manager/Senior Manager- Clinical Development in Guragon, India
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 Clinical Development Consultant (CDC) is responsible for the management of clinical sites being considered and/or participating in Lilly clinical trials; inclusive of site identification and qualification, the timely delivery of clinical trial enrollment in accordance with scientific objectives, timely delivery of database locks, issues management at clinical trial sites, and ensuring inspection readiness at all times for assigned therapeutic area(s) within a region/country that enables global program delivery. This is achieved by the CDC’s accountability for comprehensive site management, leveraging of information/tools to make/have informed decisions and discussions, and high quality interactions with global clinical trial sites to drive to an unparalleled customer experience.
The CDC is also responsible for oversight of vendor monitoring activities at clinical trial sites, including the identification, mitigation and escalation of significant findings and trends. Additional local responsibilities may be required as needed/appropriate for the local geography.
Clinical Investigator Management
Accountable for activities required at clinical trial sites and by investigators and site staff participating in Lilly trials; inclusive of site identification and qualification, enrollment planning and execution, to database lock and close out
Accountable for comprehensive site management activities to ensure timely delivery of enrollment readiness, trial recruitment/enrollment and database locks; inclusive of performance management and issue mitigation, identification and resolution
Responsible for identifying potential opportunities to accelerate trial enrollment, while driving to an unparalleled clinical trial/customer experience
Accountable for the application of scientific, therapeutic area, and institutional/regional expertise to inform and ensure timely delivery of trial enrollment and quality data
Accountable for the development of strategic institutional/site relationships to optimize the delivery of clinical trial programs; including across therapeutic areas where applicable
Clinical Trial Management
Responsible for the development and implementation of applicable site risk plans to ensure delivery of clinical trial enrollment commitments and database locks
Ensure site and country level inspection readiness at all times
Leverage metrics to inform site/country/regional level decision making
Work with internal and external teams to remove barriers to trial execution at a site and/or country level
Responsible for understanding local treatment paradigms and standard of care to support targeted feasibility and strategic allocation of trials as required
Provide vendor oversight for site monitoring activities at site/country level
Business Management and Engagement
Establishes and develops strong professional relationships with active/potential clinical investigators to expand/maintain clinical research partnership opportunities and provide an unparalleled experience for participation in Lilly clinical trials.
Cross functional collaboration and partnership to ensure alignment in priorities and deliver the portfolio
Perform targeted sites prospecting in alignment with portfolio strategy & priority
Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel
Serve as an effective communication “bridge” between sites, third party vendors and Lilly
Influence and challenge internal and external factors in order to improve clinical research delivery
Minimum Qualification Requirements:
Bachelor's degree or equivalent in a scientific or health-related field
Minimum of 5 years experience in the pharmaceutical industry and/or clinical research and strong working knowledge of Good Clinical Practice
Therapeutic expertise and knowledge of the clinical research landscape; ability to acquire and maintain therapeutic expertise to support portfolio needs
Strong self-management and organizational skills; ability to manage workload, set personal priorities and adjust as needed
Demonstrated strategic agility & broad business acumen
Demonstrated leadership behaviours with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainty
Other Information/Additional Preferences:
Strong communication (both verbal and written) and language skills
Strong organisational/planning skills
Demonstrated ability to enhance/improve customer experience
Fluent in English as well as required language to conduct day-to-day business
Strong knowledge in country regulatory guidelines/requirements
Strong teamwork and interpersonal skills
Demonstrated decision-making ability
Ability to develop and apply creative solutions
Travel required (50-75%)
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 ( LillyRecruitingCompliance@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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
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