Consultant-Clinical Development, Atlanta, GA
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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 39,000 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.
Do you have a passion for clinical trials? Are you experienced in the management of clinical trial sites? Is exceptional customer and patient care important to you? If so, then we have the role for you.
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. In this role, you will have 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. Additionally, you will be responsible for oversight of vendor monitoring activities at the 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 by investigators and site staff participating in Lilly trials
- Accountable for comprehensive site management activities to ensure timely delivery of enrollment readiness, trial recruitment/enrollment and database locks 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 Responsible 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
- Utilize metrics to inform site/country/regional level decision making
- Work with internal and external groups 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 factors in order to improve clinical research delivery
- Bachelor’s degree (scientific or health- related field preferred)
- Minimum of 3 years experience in the pharmaceutical industry and/or clinical research and strong understanding of Good Clinical Practice
- Valid driver’s license and acceptable driving record
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
- 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 handle workload, set personal priorities and adjust as needed
- Demonstrated strategic agility & broad business insight Demonstrated leadership behaviours with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainity
- 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 collaboration skills Demonstrated decision-making ability
- Ability to develop and apply creative solutions
- Lilly credits its exceptional employees for its successes and knows the key to ongoing achievement lies in attracting and retaining the best people. Here are a few of the recognitions Lilly has earned for creating an outstanding work environment:
- Business Week magazine 50 Best Places to Launch a Career
- Black Enterprise 2018 list of 50 Best Companies for Diversity
- FORTUNE 50 Best Companies for Minorities Human Right Campaign Corporate Equality Index - 100% score
- Travel required (50-75%)
- Relocation is available for these roles.
- It is required that you live within 75 miles (driving distance) of the city center for the listed city or cities in this job posting
- 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
To submit resume, visit https://www.lilly.com/careers and apply to Req ID 50312.
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.
Our scientists and researchers are developing the breakthrough medicines of tomorrow. Join us and become a creative innovator and thinker who can improve the lives of millions.
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