Expert Specialist, Clinical Development

2 weeks ago

Cork, Ireland Eli Lilly and Company Full time

Expert Specialist, Clinical Development page is loaded Expert Specialist, Clinical Development Apply locations Ireland, Cork time type Full time posted on Posted 30+ Days Ago job requisition id R-61162

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 Expert Specialist /Sr. Expert Specialist provides technical and project administrative support to the Clinical Development Trial Lead (CDTLs) to help enable on-time and on-budget delivery of key tasks during clinical trial execution. The Expert Specialist/ Sr. Expert Specialist 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 setup 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 CDTLs and Management 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. study 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, 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 CDTLs and Management to generate regional-level, trial-level and compound-level milestone and budget reports, enrolment 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 Ireland. Lilly does not anticipate providing sponsorship for employment visa 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 ( Lilly_Recruiting_Compliance@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.

#WeAreLilly

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