Eli Lilly and Company · 23 hours ago
Clinical Trial Project Manager, Clinical Delivery - EMP
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$65K/yr - $165K/yr
3+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. The Clinical Trial Project Manager will lead study teams in the planning and execution of Phase 1 clinical studies, ensuring quality and timely delivery of study deliverables while managing budgets and risks.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Plans and implements study management activities including timeline, risk, and budget management, etc
Serves as the trial level owner of communication across functional personnel TPO (Third Party Organization), communication of timelines, unanticipated issues, and solutions and actions for which such personnel are held accountable
Proactively identifies and communicates appropriately the status of ongoing projects, issues, and risks that may affect the project schedule and delivery of the study
Provides oversight and/or approval of cross-functional vendor results
Partners with exploratory and bio-pharmaceutics clinical development colleagues to obtain study cost estimates. Tracks study-level spend and change needs
Anticipates, manages, and escalates issues as appropriate
Holds business partners accountable to agree upon expectations and results
Interacts closely with the TPO to plan and execute the study at each site
Partners to identify, qualify, and select sites
Partners with cross-functional personnel to develop and negotiate detailed clinical study budgets
Partners with Contracts personnel to initiate contracts
Leads and tracks investigator payments, when needed
Ensure site initiation, monitoring and close out visits are performed by the site monitor. Reviews monitoring reports as applicable and ensure solutions/follow up of data queries and coordinating issues. Advances unresolved quality and/or performance issues, as vital
Provides cross-functional clinical process expertise and input for timeline development as the need arises
Leads study development in coalition with internal and external partners
Initiates contracts with investigators, consultants, and other external entities, as appropriate
Communicates study-level requirements to vendors and reviews third party tasks (including data acquisition, dataset requirements, database build) to ensure they meet protocol requirements and other Lilly requirements and adhere to oversight plan
Consults with internal and external partners to ensure feasibility of enrollment plan, study design, and understanding of local regulatory and ethics approval requirements for successful protocol implementation
Develops and/or approves trial level site activation documents (e.g., Monitoring Plan, Investigator Training)
Plans, runs, and supervises study enrollment
Partners with Product Delivery to ensure accurate labeling, creation of drug accountability forms, reconciliation of unblinding summary, and other CT (Clinical Trial) material issues
Proactively ensures complete documentation for protocol violations, investigator/ERB information, and other elements required for the clinical study report or submission
Ensures study level safety review is planned and performed
Ensures inspection-ready maintenance and archiving of TMF (Trial Master File)
Ensures Vault Clinical data accuracy and completeness
Partake in responses to inspections, assessment, and audits
Answers protocol and technical questions from customers and business partners
Ensures user needs are met in device design considerations and the development of user instructions and training materials, as appropriate
Provides scientific consultation for clinical and regulatory documents such as study protocols, Investigation Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, study reports, abstracts, publications, and manuscripts
Consults on and/or drafts responses to questions from Regulatory Agencies and affiliates
Qualification
Required
Bachelor's degree (scientific or health‑related field preferred) AND at least 3 years of clinical research experience or relevant experience in a scientific or health‑related field; OR
Advanced degree (Master's, PharmD, PhD, etc.) in a scientific, health‑related, or relevant field
Strong leadership and networking skills
Communicates effectively
Proven problem-solving abilities
Strong self-management, organizational and interpersonal skills
Strong verbal reasoning, detail, critical thinking, problem solving, and analytical abilities
Previous experience working in cross-functional teams or projects
Ability to travel (up to 10% expected – varies dependent on responsibilities)
Proven track record to work effectively cross-culturally and in a virtual work environment
Understanding of regulations and guidelines that apply to conduct of studies
Strength in Excel, Project, risk management tools, budget monitor & control tools
Preferred
Prior pharmaceutical development broadening experience preferred
Benefits
Company bonus (depending, in part, on company and individual performance)
Eligibility to participate in a company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-01-23
Company data provided by crunchbase