Lilly Consultant-Clinical Business Operations in Indianapolis, Erl Wood, Indiana
Are you considered an expert of your function? Do you seek knowledge from various sources to craft development plans and continuous improvement opportunities? Can you guide the development of studies and the execution of support activities while working with others? Clinical Pharmacology, at Lilly, provides industry leading expertise and capabilities in early phase development and delivers efficient clinical plans, high quality submissions and approvals. The organization strengthens the impact of exploratory medicine through the integration of translational medicine.
As Clinical Business Operations Consultant, you will provide operational leadership and lead a team of skilled Operations Associates. In addition to knowledge of ICH and quality guidelines needed for successful delivery of the portfolio and clinical trials, you will possess the business insight, process knowledge, and influence required to lead in process and quality improvement efforts. You will also seek knowledge from internal and external sources and use this information to shape development plans and continuous improvement opportunities. Key responsibilities of this role include:
Study Development and Execution Support
Establish networks with other key support areas to efficiently and effectively support exploratory and bio-pharmaceutics clinical studies.The team will support study development by owning updates to corporate systems and processes eg CT Registry, IMPACT; trial and compound level documentation management eg eTMF and the contracting elements for a study.
Provide leadership in business interactions with TPO partners; helping to execute the exploratory and biopharmaceutics clinical development portfolio. Involved in the issue escalation and relationship management processes,vendor and clinical research unit assessments as appropriate.
Maintain awareness of regulatory issues and trends relevant to assigned portfolio.
Cross-Functional Systems and Processes
Provide leadership in business processes supporting early phase development.
Established expertise on key business systems that support exploratory and bio-pharmaceutics clinical development..
Review of established procedures across multiple subject areas, dependent on the change agendas to be evaluated and prioritized. Give to the overall strategic direction.
Draw on deep exploratory and bio-pharmaceutics clinical development knowledge and process expertise to review processes and when necessary sponsor improvement initiatives to increase business efficiency and value.
Ensure cross-functional process alignment internally and externally where appropriate
Act as a key resource to internal governance committees regarding processes utilized in the exploratory and bio-pharmaceutics clinical development
Ensure optimal network with the Quality, CIPA, and L&D organizations is established in order to guarantee processes deliver on Quality and Regulatory compliance requirements
Metrics and Reporting
Drive definition of metrics or measures to quantify portfolio deliverables and assess process effectiveness
Develop a metrics / measures and evaluation strategy for the organization. Establish and operationalize the processes to support this strategy e.g. scorecard generation
Monitor implementation progress and/or recommend corrective actions.
People Management and Employee Development
Attract, retain and develop a diverse workforce.
Model behaviors and establish an environment where performance and results are valued, and where individuals are learning and growing developmentally.
Seek opportunities to reward and recognize individuals and teams.
Provide encouraging environment for staff to explore innovative solutions to business problems and implement strategic and tactical decisions.
Contribute to succession planning, talent assessment and performance/promotion processes. Ensure high talent staff are appropriately rewarded and developed.
Coach and mentor department personnel, and as needed, cross-functional members.
Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
Proven project management and time management skills.
Willingness to work effectively cross-culturally and in a virtual work environment.
Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships.
Strong organizational and interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.
Strong verbal reasoning, attention to detail, critical thinking, problem solving, and analytical abilities.
Supervisory experience with experience coaching and mentoring others.
Advanced scientific degree
Deep expertise in one or more clinical research functions (clinical operations, sourcing, data sciences, or medical writing)
Vendor management and contracting experience.
Exploratory and bio-pharmaceutics clinical development, quality and Six Sigma experience preferred.
- 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.
Senior Associate-Clinical Business Operations
Bachelor’s degree in a science related discipline.
3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies
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.
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.
Indianapolis, Erl Wood
United Kingdom, USA
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Europe; Middle East; Africa, North America