Sr. Specialist/Expert Specialist

10 hours ago

Cork, Ireland Eli Lilly and Company Full time

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. Our 45,000 employees 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. Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 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. In-house 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. 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

Organization Overview:
The purpose of the CLS Specialist is to serve a pivotal role in the creation of a clinical trial laboratory database, tracking of clinical trial samples from the point of collection through testing, ensuring Lilly has received the data generated from those laboratory samples, and assisting in the preparation of study database locks. This position will also provide technical, process and logistical support as it relates to the management of the laboratory database and sample/data tracking. This role requires understanding of CLS processes, central laboratory processes, clinical sample processing, and data lock processes. The CLS Specialist will partner with the CLS Associates, CLS Consultants, CSSP (Labs Connect support), and central laboratories to ensure the databases are set up as expected, and enable tracking of the laboratory samples and data.

Responsibilities:

- Communication/Information Management

- Manage investigator and study team requests for access to central laboratory vendors’ site portals and provide reports to CLAs/teams regarding user access listings.

- Maintain a tracker of initial kit shipments to investigator sites and other study start-up reports.

- Assist with study start-up processes such as obtaining necessary import of record (IoR) information from the study team.

- Utilization of the SMaRT system related to sample tracking from the sites to the testing laboratories.

- Serve as the query escalation point for CLS by communicating with CRAs responsible for the site.

- Prepare and submit laboratory panic/hepatic/toxicity alert emails to the study team.

- Upload study documents into the electronic trial master file (eTMF).

- Review and set-up Protocol Specific Addendum (PSA) for clinical trials.

- In partnership with the CLA, manage the process of database lock preparation.

- Provide technical and logistical consultation regarding laboratory database creation, sample and data tracking.

- Maintain open lines of communication with management, customers, and vendors.

- Perform all additional tasks given by the CLS Management.

- Process Application and Improvement

- Develop and implement training activities and materials related to department processes.

- Understand/recognize process issues and/or gaps and drive to resolution.

- Participate in functional and cross-functional process improvement initiatives.

- Work to improve existing processes and to implement new processes in an efficient manner.

- Self-Improvement

- Maintain compliance with all departmental, Medical Quality System (MQS) and Lilly Research Laboratory (LRL) training requirements.

- Participate fully in performance management process.

Basic Requirements:

- Bachelors Degree in Medical, Science or related field.
- 1-2 years professional experience.
- Proficiency in working with data in spreadsheets.
- Strong communications skills (both verbal and written).

Additional Skills/Preferences:

- Detail-oriented to ensure accurate work product on a consistent basis.
- Strong self-management skills.
- Strong time management and prioritization skills.
- Demonstrates strong teamwork skills and ability to influence others.
- Ability to work under tight timelines.
- Understanding of clinical laboratory processes.
- Knowledge of clinical drug development.
- Experience with laboratory information systems.
- Coding and programming experience preferred.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

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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