Expert Specialist

Job Description

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 enrolment 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

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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https: / / careers.lilly.com / us / en / workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

Role:Operations - Other

Industry Type:Pharmaceutical & Life Sciences

Department:Customer Success,Service & Operations

Employment Type:Full Time, Permanent

Role Category:Operations

Education

UG:Any Graduate

PG:Any Postgraduate

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