Expert Specialist /Sr. Expert Specialist, Clinical Development
Job Description
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
u2022 Order, track, and ship study supplies, tools, and/or instruments.
u2022 Track and report Regional/Global enrollment data for ongoing clinical studies
u2022 Perform routine study activities per policies/procedures (e.g. Study closeout)
u2022 Participate in shared learning forums.
u2022 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
u2022 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
u2022 Support backroom for regulatory and mock inspectionsu2022 Support collection and review of key information to support submission activities (i.e. collecting and verifying accurate information for financial disclosures/1572 and OSI).
u2022 Establish, maintain, and use appropriate team information repositories (e.g. study collaboration site eTMF) and maintain project team rosters.
u2022 Support filing and archiving processes- Clinical Trial Systems Management
u2022 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.
u2022 Assist in producing and distributing project status reportsu2022 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: u2022 Two-year degree or 2 years administrative or technical experience
u2022 Computer proficiency and experience using a variety of software packages (e.g., Microsoft Word, Excel, Power Point, Project)
Highly Desired Skills: u2022 Strong communication skills able to communicate clearly and succinctly with team members and leadership.
u2022 Demonstrated ability to work effectively cross-culturally as well as across regions/geographies with strong customer service skills.u2022 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.
u2022 Ability to maintain confidentiality.
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