Lilly Jobs

Job Information

Lilly Senior Manager - Trial Capabilities in Cork, Ireland

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 35,000 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.

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 35,000 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.

Purpose:

The Trial Capabilities Senior Manager leads the clinical trial capabilities in support of clinical development. The Senior Manager is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out. This includes submission of documents to regulatory authorities and Ethics Review Boards, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), assist in budget and contract negotiation. The senior manager is accountable for the prioritisation, planning and implementation of site initiation activities working closely with the site engagement at the affiliates, global study teams and the design hub ensuring accurate planning, prioritisation and timely execution to meet portfolio needs.

The senior manager provides leadership, direction and technical support to the Clinical Trial Capabilities Teams focusing on results and driving efficiency to achieve goals and objectives. The senior manager will ensure inspection readiness at all times through a complete, accurate and readily available Trial Master File.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Clinical Trial Capbilities Responsibilities

  • Accountable for meeting and exceeding goals for clinical trial initiation for development programs.

  • Accountable for ensuring site initiation and maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards.

  • Drive and ensure Site Activation strategies are created and delivered.

  • Manage communications/relationships and serve as the point of contact for the trial capabilities deliverable during site initiation, maintenance, and close out representing progress to business partners.

  • Accountable for prioritisation of work to meet portfolio needs.

  • Ensure flexilbility of resources across trial capabilities teams and geographies.

  • Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements.

  • Develop and manage strategies to improve customer experience.

  • Ensure inspection readiness through a complete, accurate and readily available Trial Master File

Organizational Leadership

  • Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within the CDO and MDU

  • Build capabilities in the function through the development and improvement of processes, tools and training and partnering with Clinical Information and Process Automation to leverage technology to increase efficiency of clinical trial capabilities and resources.

  • Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning

People Management and Development

  • Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in clinical development

  • Effectively manage an agile organization that continuously meets the needs of a changing portfolio

  • Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment based decision making in clinical delivery

Minimum Qualification Requirements:

  • Bachelor’s degree preferably in a scientific or health related field, five years clinical research experience or relevant experience preferred

  • Understanding of the overall clinical development paradigm and the importance of efficient site initiation

  • Previous supervisory experience

  • Strong leadership skills and ability to influence others and lead across the business

  • Project management processes and skills

  • Appreciation of / experience in compliance-driven environment

  • Ability to learn and comply with financial and legal guidelines and policies (budget and contract)

  • Effective communication, negotiation, and problem solving skills

  • Self-management and organizational skills

  • Language capabilities preferred

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly 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.

DirectEmployers