Lead Clinical Trial Project Management-Device

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.

As Clinical Trial Project Manager (CTPM), you will independently lead the study team in the development and execution of complex clinical trials. You will be accountable, globally, to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget. The CTPM 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 large, complex studies and/or multiple smaller studies that deliver positive patient and investigator site experiences and quality data.
• Partner with other organizations to oversee and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).
• Be accountable for enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET)
• 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.
• 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 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 CTPMs, study team members and business partners on aspects of CT process and regional specificities while maximizing shared learning.
• 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.

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 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.

Basic Qualifications

• Bachelors degree (scientific or health-related field preferred)
• 3-5 years of experience in a clinical trial related setting.
• 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.

Additional Information

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

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.

Additional Skills/Preferences

• Solid ability to lead and work effectively cross-culturally with global colleagues and with business partners to establish and maintain effective relationships.
• Be recognized as a leader with demonstrated ability to coach others in process expertise.
• Adopt strategic organizational changes and lead others effectively through these, exhibiting flexibility to adjust quickly and effectively to frequent change and altered priorities
• Ability to influence without authority
• Effective and influential communication, self-management, and organizational skills
• Ability to handle complex situations through problem-solving, critical thinking and navigating ambiguity
• 3-5 years of experience in the medical device industry
• Prior experience with and working knowledge of Good Clinical Practice (GCP) and local/country regulatory requirements, standards, and guidelines related to medical device clinical research
• Applied knowledge of project management methodology, processes and tools (e.g., MS Project, MS Excel, MS Powerpoint)
• Need to travel periodically to AST/ ISST and potentially other scientific/ regional meetings