Clinical Trial Project Manager, Clinical Delivery - EMP
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.
Purpose:
The purpose of the Clinical Trial Project Manager (CTPM) role related to exploratory, and bio-pharmaceutics clinical development is to lead study teams of internal and external partners in the planning and execution of studies within the Phase 1 clinical development plan. The CTPM achieves this while ensuring quality, on time, and on-budget fulfillment of study deliverables. The CTPM may also support non-study project assignments to transform and improve the business. The CTPM will seek knowledge from internal and external sources and use this information to shape development plans and ongoing improvement opportunities.
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. Collaborate with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Study Management
• 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.
Clinical Trial Process
• 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.
Scientific/Therapeutic Area Expertise, Application and Support
• 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.
Minimum Qualification Requirements:
• 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.
Other Information/Additional Preferences:
• 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.
• Prior pharmaceutical development broadening experience preferred
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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $148,500
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
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Purpose:
The purpose of the Clinical Trial Project Manager (CTPM) role related to exploratory, and bio-pharmaceutics clinical development is to lead study teams of internal and external partners in the planning and execution of studies within the Phase 1 clinical development plan. The CTPM achieves this while ensuring quality, on time, and on-budget fulfillment of study deliverables. The CTPM may also support non-study project assignments to transform and improve the business. The CTPM will seek knowledge from internal and external sources and use this information to shape development plans and ongoing improvement opportunities.
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. Collaborate with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Study Management
• 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.
Clinical Trial Process
• 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.
Scientific/Therapeutic Area Expertise, Application and Support
• 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.
Minimum Qualification Requirements:
• 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.
Other Information/Additional Preferences:
• 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.
• Prior pharmaceutical development broadening experience preferred
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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $148,500
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Apply Now
Apply Now