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Associate / Sr Associate - Clinical Delivery Trial Associate, EMP

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Lilly

12d ago

  • Job
    Full-time
    Mid Level
  • Research & Development
    Healthcare
  • Cork

AI generated summary

  • You need a bachelor’s in a relevant field, 3 years in pharma, strong analytical and communication skills, and experience with clinical study protocols, vendor management, and data analysis tools.
  • You will manage clinical trial documentation, support budget tracking, ensure compliance, liaise with vendors, generate reports, and maintain key business systems and processes.

Requirements

  • Bachelor’s Degree in a scientific or health-related field; or equivalent qualifications/experience (3 years pharmaceutical industry experience).
  • Strong self-management, analytical and organizational skills.
  • Demonstrated problem-solving abilities.
  • Ability to prioritize and handle a high volume of activities.
  • Proficiency with business software packages.
  • Strong communication (verbal and written) skills and willingness to collaborate globally.
  • Ability to travel (varies dependent on responsibilities – if responsibilities require travel up to 10% expected).
  • Knowledge and understanding of:
  • Technical details of clinical study protocols, especially as regards subject inclusion/exclusion criteria, schedules of events and procedures.
  • Experience with contract management with vendors and/or clinical sites.
  • Proficiency with webpage/collaboration site design and stewardship.
  • Operational data analysis in excel and various reporting systems.
  • Experience in clinical development, familiarity with medical terminology, and good clinical practice requirements.
  • Exploratory and biopharmaceutics clinical development study processes, clinical site operations.
  • Experience with Veeva Clinical, Office 365, data visualization software (e.g. Tableau Vault, PowerBI).

Responsibilities

  • Establish, maintenance and archival of compound-related files and trial-related files as required per procedures.
  • Create and maintain clinical plan and compound information in IMPACT.
  • Given a final protocol, lead the authoring of CT Registry entries at beginning of a trial.
  • Obtain or prepare relevant documentation necessary for a clinical trial based on GCP or Local regulations for Site Activation, Maintenance and Close-out (e.g. New Trial Statements for insurance certificates, copyright permissions and document translations, Clinical Trial Applications).
  • Assist in the planning, forecasting, and tracking of trial budgets, POs and invoices.
  • Support efforts in establishing consulting agreements (vendors and investigators).
  • Understand FRAP and consult with teams regarding FRAP compliance.
  • Ensure Legal, Procurement and Financial processes are completed for assigned TPOs.
  • Support study teams with sourcing activities by:
  • Gaining agreement on sourcing timelines and expectations with the team.
  • Liaising with Procurement to obtain competitive study bids.
  • Preparing Study Work Orders (SWOs) and contracts with Procurement and Legal.
  • Assists study teams with issue escalation and dispute resolution when needed.
  • Participate in ongoing business and quality reviews with TPOs.
  • Work to resolve quality issues arising from internal and external assessments and audits.
  • Work with corporate contracts group to help facilitate the FMV process.
  • Create and maintain collaboration sites at process, compound or trial levels for the organization.
  • Proactively establish and ensure accuracy and completeness of information in Veeva Vault Clinical, IMPACT, Planisware and other critical business systems, producing reports as needed.
  • Collaborate in the development and maintenance of business processes.
  • Represents the Clinical Business Operations in the assessment and contracting of potential vendors as appropriate.
  • Includes Anti-corruption due diligence.
  • Help maintain study archetype templates.
  • Support knowledge management and archival activities for the organization.
  • Provide support for tools to support portfolio delivery.
  • Provide support for Training curricula assignment and system updates.
  • Provide leadership in the Protect Lilly / Privacy / GDPR (EU) / other compliance initiatives.
  • Identify, evaluate, and interrelate data using means to advise business processes and enable organization decisions, investigate issues, and identify trends and improvement areas.
  • Create and run system reports for metrics as well as proactively address gaps in required fields.
  • Support reviews of GCP issues and compliance reporting.
  • Generate organizational metrics/measures, milestone reports, staff capacity reports, and other reports as needed (e.g. bottleneck reports).
  • Support capacity planning and accurate reporting of project time through coordination of CATS entries.
  • Support use of systems and databases (for example: Trackwise deviation or change mgmt systems).
  • Work to assess vendor performance, share TPO performance metrics with Lilly management.
  • Manage and maintain Org Charts and Job Descriptions.

FAQs

What is the primary purpose of the Clinical Delivery Trial Associate role at Lilly?

The primary purpose of the Clinical Delivery Trial Associate role is to serve as a technical and process expert in exploratory and biopharmaceutics clinical development, supporting the portfolio, clinical trials, and business processes.

What types of degrees are acceptable for this position?

A Bachelor’s Degree in a scientific or health-related field or equivalent qualifications/experience (3 years of pharmaceutical industry experience) is acceptable for this position.

Is prior experience in clinical development necessary for this role?

While not explicitly required, familiarity with clinical development, medical terminology, and good clinical practice requirements is preferred.

What types of systems will I be using in this position?

In this role, you will use systems such as Veeva Vault Clinical, IMPACT, Planisware, and other critical business systems for various tasks including reporting and data management.

What are the travel requirements associated with this job?

The role may require travel up to 10%, depending on specific responsibilities.

Are there opportunities for career development at Lilly?

Yes, Lilly offers in-house people development services, educational assistance, and various wellbeing initiatives that enhance the career experience.

What is the expected workload in this position?

The role involves managing a high volume of activities, so strong self-management, analytical, and organizational skills are essential.

Are there specific software skills required for this job?

Proficiency with business software packages and operational data analysis in tools like Excel and various reporting systems is required.

What diversity initiatives does Lilly support?

Lilly is committed to providing equal employment opportunities and does not discriminate based on age, race, religion, gender, sexual orientation, gender identity, national origin, disability, or any other legally protected status.

Does Lilly provide additional benefits, such as health benefits and wellness programs?

Yes, Lilly offers a range of benefits including healthcare, pension, life assurance, a subsidized canteen, onsite gym, travel subsidies, and wellness initiatives.

Lilly

We're a medicine company turning science into healing to make life better for people around the world.

Manufacturing & Electronics
Industry
10,001+
Employees
1876
Founded Year

Mission & Purpose

Eli Lilly and Company is a global pharmaceutical firm dedicated to discovering, developing, and delivering innovative medicines that improve patient outcomes worldwide. Their ultimate mission is to make life better for people around the globe through high-quality healthcare solutions. The purpose of the company is to create medicines that help people live longer, healthier, and more active lives, while maintaining a commitment to ethical standards, scientific excellence, and integrity in all their operations.