[Remote] Clinical Trial Project Manager, Clinical Delivery - EMP

Note: The job is a remote job and is open to candidates in USA. Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking a Clinical Trial Project Manager to lead study teams in the planning and execution of clinical studies, ensuring quality and timely deliverables while managing budgets and risks.

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 arenaflex 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 Skills
• 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
• 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
• Prior pharmaceutical development broadening experience preferred Benefits
• Company bonus
• 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 Overview
• We're a medicine company turning science into healing to make life better for people around the world. It was founded in 1876, and is headquartered in Indianapolis, Indiana, USA, with a workforce of 10001+ employees. Its website is Company H1B Sponsorship
• Eli Lilly and Company has a track record of offering H1B sponsorships, with 514 in 2025, 236 in 2024, 167 in 2023, 133 in 2022, 57 in 2021, 52 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job

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