Posted in General Business 30+ days ago.
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 39,000 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 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 39,000 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. #WeAreLilly
The purpose of the Clinical Trial Project Management (CTPM) role related to the exploratory and biopharmaceutics clinical development is to lead study teams of internal and external partners in the planning and execution of studies within the clinical 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 candidate will seek knowledge from internal and external sources and use this information to shape development plans and continuous improvement opportunities.
Plans and executes study management activities including timeline, risk management, budget monitor & control, etc.
Serves as the focal point of study-level communication between internal and external partners.
Proactively identifies and communicates appropriately the status of ongoing projects, issues, and risks that may affect the impact chain of the study and project schedule.
Provides oversight and/or approval of cross-functional vendor deliverables.
Partners with exploratory and biopharmaceutics clinical development colleagues to obtain study cost estimates. Tracks study-level spend and change needs.
Anticipates, manages, and advances issues as appropriate.
Serves as the trial level owner of communication across functional personnel and CRO, keeping all contacts informed of timelines, unanticipated issues, and solutions and actions for which such personnel are held accountable.
Holds business partners accountable to agreed upon expectations and deliverables.
Interacts closely with the investigator sites 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 with investigator sites.
Manages and tracks investigator payments, when needed.
Either performs site initiation, monitoring and close out visits or co-ordinates these with a site monitor. Write or review monitoring reports as applicable and ensure resolution/follow up of data queries and monitoring issues. Raise unresolved quality and/or performance issues as necessary.
Clinical Trial Process
Provide cross-functional clinical process expertise and input for Critical Chain planning as required.
Leads study development in partnership with internal and external partners.
Initiates contracts with investigators, consultants and other external parties, as appropriate.
Communicates study-level requirements to vendors and reviews third party tasks (including data acquisition, dataset requirements, database design) 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 (depending on site monitoring sourcing model) trial level site activation documents (e.g. Monitoring Plan, Investigator Training.
Plans, manages and tracks study enrollment.
Partners with Product Delivery to ensure proper labeling, creation of drug accountability forms, reconciliation of unbinding summary, and other CT material issues.
Proactively ensures complete documentation for protocol violations, investigator/ERB information, and other elements that are required for the clinical study report or submission.
Ensures study level safety review is planned and performed.
Ensures inspection-ready maintenance and archiving of paper and electronic study-level documentation (e.g. TMF).
Ensures IMPACT data accuracy and completeness.
Participates 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:
Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree
Other Information/Additional Preferences:
Demonstrated ability to work effectively cross-culturally and in a virtual work environment.
Strong knowledge of regulations and guidelines that apply to conduct of studies.
Proficiency in Excel, risk management tools, budget monitor & control tools.
Strong leadership and networking skills.
Strong communication skills.
Demonstrated problem-solving abilities
Strong self-management, organizational and interpersonal skills.
Strong verbal reasoning, attention to 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)
Passionate about improving technological solutions using new and emerging technologies
Ability to balance multiple activities, prioritize and manage ambiguity
Demonstrated exemplary teamwork/interpersonal skills
Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and 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.