Senior Manager - Trial Capabilities

at  Lilly

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.
At Eli Lilly Cork, 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 41,000 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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

PURPOSE:

The Senior Manager Trial Capabilities leads the clinical trial capabilities in support of clinical development. This includes leading the countries in the region that provides the global clinical trial capabilities in support of global clinical development. In this role the Sr Manager.is accountable for site activation/management/closeout, site contracting, clinical finance, records management, training, and trial metrics across all therapeutic areas. The Sr Manager will serve as the point of contact for Competent Authority (CA)(where applicable), assist in budget and contract negotiation. Additional local responsibilities may be required as needed/appropriate for the local geography, and/or to cover regional differences
The Sr manager is accountable for the prioritisation, planning and implementation of site initiation activities working closely with the Trial Capabilities team, site engagement at the affiliates, global study teams and the design hub ensuring accurate planning, prioritisation and timely execution to meet portfolio needs.
The Sr 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 Sr manager will ensure inspection readiness at all times by following GCP requirements and 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 in the region of responsibility.
• 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 representing progress to business partners internally and externally.
• Support global solutions across geographic regions and in conjunction with other clinical development and MDU functions
• 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.