Clinical Development Consultant, Site Engagement - Ontario
Company OverviewLilly is one of the top 10 largest pharmaceutical companies in the world. Lilly has remained dedicated to creating medicines that help improve peoples' quality of life for more than 140 years. At the heart of Lilly's operations are its core values – excellence, integrity and respect for people and these are reflected in business practices that include strong governance principles, the ethical development of medicines, transparency and ethical product promotion.
ResponsibilitiesThe 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 unparalled 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.
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.
1. Clinical Investigator Management
- Accountable for activities required at clinical trial sites 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
2. 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
3. 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
- Bachelor’s degree or equivalent in a scientific or health-related field
- Minimum of 3 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 behaviors with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainty
- Strong communication (both verbal and written) and language skills
- Strong organizational/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%)
To submit resume, visit https://www.lilly.com/careers and apply to Req ID 55595.
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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