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Pharmacoepidemiology Project Manager Associate

Cork, Ireland

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Req ID R-20326 Title Pharmacoepidemiology Project Manager Associate City Cork State / Province Cork Country Ireland Region Research

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 35,000 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.

Purpose:
The purpose of the Pharmacoepidemiology Project Management (PEPM) Associate 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 PEPM achieves this while ensuring quality on-time and on-budget fulfillment of study deliverables. The PEPM may also support non-study project assignments to transform and improve the business. The Associate will seek knowledge from internal and external sources and use this information to shape development plans and continuous 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.  Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
1.    Study Management
    Plans and executes study management activities including timeline, 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.
    Tracks study-level spend and change needs. 
    Anticipates, manages, and escalates issues as appropriate. 
    Serves as the study 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. 

2.    Observational Study Process
    Provide cross-functional clinical process expertise.
    Leads study development in partnership with internal and external partners.
    Initiates contracts with outside consultants and ensures payments abide by fair market value. Working with internal groups, 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 internal partners (Business Units, Ad Promo, etc) for review of websites, recruitment materials, and labeling updates.  
    Proactively ensures complete documentation for study decisions (issue decision log up to date), investigator/ERB information, and other elements that are required for the study report or submission.
    Ensures inspection-ready maintenance and archiving of paper and electronic study-level documentation
    Support backroom  for regulatory and mock inspections
    Ensures IMPACT data accuracy and completeness.
    Participates in responses to inspections, assessment and audits.

3.    Operational Area Expertise, Application and Support
    Provides 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.
    Initiates confidentiality disclosure agreements (CDA’s) as needed with outside consultants and vendors
Minimum Qualification Requirements:
•    Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical and/or observational research experience or relevant experience in a scientific or health-related field; or an advanced degree
•    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)
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 Office 365, MS Teams, budget monitor & control tools.

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 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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-20326.

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.

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