Lilly Assistant, Clinical Trial Project Management (CTPMA) 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.
The Clinical Trial Project Management Assistant (CTPMA) provides technical and project administrative support to the Clinical Trial Project Managers (CTPM) and Clinical Development Organization (CDO) leadership to help enable on-time and on-budget delivery of key tasks during clinical trial execution. The CTPMA supports trial, asset, and portfolio level tasks that may be assigned to a specific asset team(s) or centrally across a Therapeutic Area (TA)/Business Unit (BU).
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 Execution
Assist in the management of study budgets including the set up of purchase orders and e-requisitions
Order, track, and ship study supplies, tools, and/or instruments
Track and report Regional/Global enrollment data for ongoing clinical studies
Perform routine study activities per policies/procedures (e.g. Study closeout)
Participate in shared learning forums
May assist with other appropriate trial level activities as needed (i.e. coordination of regional and trial project-related meetings, structure of newsletters, uploading minutes to the study collaboration site(s) or eTMFs as appropriate, etc.)
Clinical Trial/Submission Documentation
Support and partner with CTPM and Clinical Development Manager to oversee maintenance and inspection readiness of study files (e.g. eTMF, study collaboration sites, etc.) including quality reviews (routine and pre-inspection), associated updates, and indexing
Support backroom for regulatory and mock inspections
Support collection and review of key information to support submission activities (i.e. collecting and verifying accurate information for financial disclosures/1572 and OSI)
Establish, maintain and use appropriate team information repositories (e.g. LillyNet Collaboration Site; eTMF) and maintain project team rosters.
Support filing and archiving processes
Clinical Trial Systems Management
Accurately input study timelines and other trial level required fields into clinical trial database (IMPACT), monitors and updates fields as study timelines or other information changes, and troubleshoots illogical data
Assist in producing and distributing project status reports
Coordinate with Clinical Trial Project Managers and Clinical Development Managers to generate regional-level, trial-level and compound-level milestone and budget reports, IMPACT accuracy and completeness reports, staff capacity reports, and other reports as needed.
Minimum Qualification Requirements:
Two-year degree or 2 years administrative or technical experience
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.
Computer proficiency and experience using a variety of software packages (e.g., Microsoft Word, Excel, Power Point, Project)
Highly Desired Skills:
Strong communication skills; able to communicate clearly and succinctly with team members and leadership
Demonstrated ability to work effectively cross-culturally as well as across regions/geographies with strong customer service skills
Strong teamwork and interpersonal skills including demonstrated ability to flex to changing business needs, attention to detail, strong self-management, organizational skills, and problem solving
Ability to maintain confidentiality
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.