BioSpace
Associate Director – Clinical Trial Foundations
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 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.
Purpose The Associate Director, Clinical Trial Foundations (CTF), will serve as the subject matter expert for clinical systems supporting clinical development. In this role, you will define and execute implementation plans to deliver on the system strategies, integrations and improvements. The focus of this role will be to support data collection systems, primarily focused on EDC and data aggregation systems. The Associate Director is responsible for collaborating with business partners to enable development, implementation and support of streamlined, clear and compliant systems to support clinical development. This role will also work closely with external parties including vendors, industry authorities and related organizations to optimize Lilly’s capabilities to support business and customer-focused, efficient clinical development.
Responsibilities
Clinical Information Systems Expertise: Understand business strategies, processes and technology as it relates to clinical development
Serve as domain expert to ensure data, process and/or technology interfaces are optimized across other clinical information systems that are integrated with these systems
Support internal audits and external inspections
Project Management: Define, lead and execute implementation plans to deliver on technology strategies and improvements
Develop critical success factors for pilots/projects and monitor progress to ensure clear criteria exists to enable decision making
Identify, monitor and communicate global customer (internal and external) needs/requirements related to process and/or technology performance and improvements
Lead organizational change, communication planning and training initiatives
Provide guidance and consulting into forecasting expenses
Identify project implementation and system execution risks and raise issues appropriately
Lead progress reporting activities and system metrics to leadership, process owners and end users
Partnership: Partner with process owners, leadership, Quality and Information Technology to ensure capable, integrated and efficient system usage across the portfolio
Actively participate in shared learning across the team
Work with vendors to improve customer experience and efficiencies
Collaborate with stakeholders for new system implementation
Minimum Qualifications
Bachelor’s degree in a scientific or health related field
Minimum 3 years’ experience in medical, quality, clinical drug development, or clinical information flow
Deep knowledge of data collection and aggregation systems (prefer experience with Veeva EDC and CDB)
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
Preferred Qualifications
Experience in clinical development systems as well as current and evolving technologies to support clinical development
Deep knowledge of cyber security, privacy, and or information security
Strong understanding of labs, including data flow and data management
Knowledge and/or experience in project management and organizational change with Lilly staff and external parties including vendors, industry experts and related organizations
Good interpersonal and leadership skills
Excellent oral and written communication skills
Strong business insight
Demonstrated strength in logical thought, problem solving ability and critical thinking
Ability to communicate and influence across functional boundaries
Ability and experience in positively handling and resolving conflict
Flexibility in approach; able to adjust to unexpected business opportunities while also being a catalyst for change
Knowledge of regulatory and quality requirements governing clinical development
Indianapolis based
10% or less travel
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $111,000 - $162,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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Purpose The Associate Director, Clinical Trial Foundations (CTF), will serve as the subject matter expert for clinical systems supporting clinical development. In this role, you will define and execute implementation plans to deliver on the system strategies, integrations and improvements. The focus of this role will be to support data collection systems, primarily focused on EDC and data aggregation systems. The Associate Director is responsible for collaborating with business partners to enable development, implementation and support of streamlined, clear and compliant systems to support clinical development. This role will also work closely with external parties including vendors, industry authorities and related organizations to optimize Lilly’s capabilities to support business and customer-focused, efficient clinical development.
Responsibilities
Clinical Information Systems Expertise: Understand business strategies, processes and technology as it relates to clinical development
Serve as domain expert to ensure data, process and/or technology interfaces are optimized across other clinical information systems that are integrated with these systems
Support internal audits and external inspections
Project Management: Define, lead and execute implementation plans to deliver on technology strategies and improvements
Develop critical success factors for pilots/projects and monitor progress to ensure clear criteria exists to enable decision making
Identify, monitor and communicate global customer (internal and external) needs/requirements related to process and/or technology performance and improvements
Lead organizational change, communication planning and training initiatives
Provide guidance and consulting into forecasting expenses
Identify project implementation and system execution risks and raise issues appropriately
Lead progress reporting activities and system metrics to leadership, process owners and end users
Partnership: Partner with process owners, leadership, Quality and Information Technology to ensure capable, integrated and efficient system usage across the portfolio
Actively participate in shared learning across the team
Work with vendors to improve customer experience and efficiencies
Collaborate with stakeholders for new system implementation
Minimum Qualifications
Bachelor’s degree in a scientific or health related field
Minimum 3 years’ experience in medical, quality, clinical drug development, or clinical information flow
Deep knowledge of data collection and aggregation systems (prefer experience with Veeva EDC and CDB)
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
Preferred Qualifications
Experience in clinical development systems as well as current and evolving technologies to support clinical development
Deep knowledge of cyber security, privacy, and or information security
Strong understanding of labs, including data flow and data management
Knowledge and/or experience in project management and organizational change with Lilly staff and external parties including vendors, industry experts and related organizations
Good interpersonal and leadership skills
Excellent oral and written communication skills
Strong business insight
Demonstrated strength in logical thought, problem solving ability and critical thinking
Ability to communicate and influence across functional boundaries
Ability and experience in positively handling and resolving conflict
Flexibility in approach; able to adjust to unexpected business opportunities while also being a catalyst for change
Knowledge of regulatory and quality requirements governing clinical development
Indianapolis based
10% or less travel
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $111,000 - $162,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#J-18808-Ljbffr