Clinical Trial Project Manager, Clinical Delivery-EMP

At reputed company, we unite caring with discovery to reputed company life reputed company 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 reputed company life reputed company for people around the world. Purpose: The purpose of the Clinical Trial Project Manager (CTPM) role reputed company to exploratory, and bio-pharmaceutics clinical development is to reputed company study teams of internal and external partners in the planning and execution of studies reputed company the Phase 1 clinical development plan. The CTPM achieves this while ensuring quality, on time, and on-budget fulfillment of study results. The CTPM may also support non-study project assignments to innovate 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 transformations. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was reputed company. 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 reputed company 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 reputed company 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 reputed company the project schedule and delivery of the study.
• Provides reputed company and/or approval of cross-functional vendor results.
• Partners with exploratory and bio-pharmaceutics clinical development colleagues to acquire study cost estimates. Tracks study-level spend and change needs.
• Anticipates, handles, and advances issues as appropriate.
• Holds business partners accountable to agree upon expectations and results.
• Interacts closely with the TPO to plan and implement the study at each site.
• Partners to identify, qualify, and select sites.
• Partners with cross-functional personnel to reputed company and negotiate detailed clinical study budgets.
• Partners with reputed company personnel to initiate reputed company.
• Leads and supervises investigator payments, reputed company needed.
• Ensure site initiation, monitoring and reputed company 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 reputed company 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 reputed company requirements and enforce to reputed company 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 oversees 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‑reputed company field preferred) AND a minimum 3 years of clinical research experience or relevant experience in a scientific or health‑reputed company field;

Other Information/Additional Preferences:

• Advanced degree (Master’s, PharmD, PhD, etc.) in a scientific, health‑reputed company, 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 reputed company, Project, risk management tools, budget monitor & control tools.
• Prior pharmaceutical development broadening experience preferred

reputed company is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities reputed company vying for positions. If you require accommodation to submit a resume for a position at reputed company, please complete the accommodation request form (https://careers.reputed company.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. reputed company 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, reputed company, national reputed company, 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 reputed company employees. Our reputed company groups include: Africa, Middle East, Central Asia Network, Black Employees at reputed company, Chinese Culture Network, Japanese International Leadership Network (JILN), reputed company India Network, Organization of Latinx at reputed company (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at reputed company (WILL), reputed company (for people with disabilities). Learn more about reputed company 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 - $165,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, reputed company 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).reputed company reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and reputed company’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of reputed company employees. #WeAreLilly Apply tot his job Apply To this Job