Are you seeking a career that makes a difference in the world? Are you an innovative thinker who can craft strategic solutions to deliver a continuously changing health care environment? Do you seek the opportunity to demonstrate your scientific and operational knowledge to impact clinical trial design, feasibility and implementation? Have you prepared or provided technical support for clinical and regulatory documents? We have the role for you if you are looking for your next career move.
Exploratory Medicine and Pharmacology, at Lilly, provides industry leading expertise and capabilities in early phase development and delivers efficient clinical plans, execution and high quality submissions documents. As Clinical Project Manager (CPM), you will independently lead the compound and study teams in the development and execution of the exploratory and bio-pharmaceutics clinical operational development plan at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan. The CPM consistently demonstrates leadership and influence when working with study teams, management, and business partners. You will work with diverse teams to apply creative solutions to complex and key technical operational or business problems. This will include opportunities to work with vendors, affiliates/regions, global teams, and other business partners. Responsibilities of this role include:
Demonstrating and Growing Clinical Trial/Drug Development Expertise
Lead, influence and project manage phase 1 (early exploratory trials and biopharm) complex studies that deliver positive patient and investigator site experiences with quality data.
Serve as the central contact for the global clinical team, to resolve clinical implementation issues, lead risk assessments and contingency planning, and effective communication across and upward
Accountability for trial documentation and ensuring inspection readiness of respective clinical trial(s) at all times. This includes timely documentation of deviations, creation of storyboards or issue summary documents (e.g. for high risk areas/hot topics) and coaches others CTPMs and study team in these activities.
Lead vendor qualification process, selection, and oversight to deliver the clinical project
Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials.
Problem Solving and Leadership Development
Utilize expertise to make timely decisions for ambiguous and complex situations. Uphold a consistent, solution-focused approach to conducting daily business.
Recognize inter-relatedness of cross-study team activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise across study teams and external partners and make decisions on process and issues affecting study implementation and execution.
Network and apply expertise to anticipate trial and regional issues, identify areas of process breakdown, analyze situations and propose innovative approaches that positively impact the ability to deliver while reducing and/or mitigating risks.
Contribute to the development of others by acting as a coach for peers as well as new CPMs, study team members and business partners to maximize learnings.
Identify and lead process improvement activities. Acts as an expert resource to peers and in the development and rollout of new tools, processes or methodologies to proceed as quickly as the science allows.
Utilize and demonstrate broad understanding of therapeutic, clinical product development, and process expertise in order to influence study design and program-level decisions considering customer needs.
Internal Number: 48859
About Eli Lilly & Company
Company Overview 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 worldwide 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.