Senior Associate/Manager

6 months ago

Cork, Ireland Lilly Full time

We’re looking for people who are determined to make life better for people around the world.

At Eli Lilly Cork, 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 41,000 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 patients around the world. Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.

Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself

Purpose:
The Clinical Development Trial Lead (CDTL) Associate leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The CDTL Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables.
 

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.


Trial Leadership, and Regional Operational Knowledge -

Use processes and tools to develop, execute, and deliver local, regional and/or global clinical trials as described below:

Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes (per change control process) as needed to meet the deliverables of the trial. Timeline – Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies. Risk - Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan. Budget - Understand the cross-functional, trial-level budget components. Create and monitor the grants and non-grants, and assumptions using financial tracking tools. Routinely network with appropriate business partners on trial-level budget status and changes. Partner with other organizations to coordinate and deliver Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs)/Investigator Engagement Meetings. Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution. Be accountable for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET) Partner with the Investigator Engagement organization to achieve regional enrollment goals. Manage relationships and serve as a single point of contact and central owner for trial communication, to and from the Clinical Design and Delivery organization, all cross functional team members, and Third Party Organization (TPOs). Apply problem-solving skills to daily issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners). Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc. Manage TPO qualification process, selection, and oversight.


Clinical Trial Process Leadership and Expertise -

Demonstrate understanding of drug development process. Acknowledge inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise. Be knowledgeable of the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams. Single point of accountability for the Trial Master File, working closely with functional record owners to ensure the file is current and inspection ready at all times. Network and leverage expertise to anticipate trial and regional issues, identify areas of process breakdown, assess situations and propose proactive approaches that reduce and/or mitigate risks that impact ability to deliver the clinical trial. Demonstrate ability to lead and influence in the midst of ambiguity. Coach peers, cross-functional team members and TPOs on aspects of clinical trial process and regional specificities. Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements.


Scientific Expertise -

Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates. Combine scientific clinical trial operational knowledge, and process expertise to impact clinical trial design, feasibility implementation, and execution. Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business and clinical programs.


Minimum Qualification Requirements:

Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant clinical trial experience in a scientific or health-related field; or an advanced degree.

Highly Desired Skills:

Applied knowledge of trial execution methodology, processes, and tools Demonstrated ability to work cross-culturally with global colleagues and with TPOs Ability to influence without authority Strong leadership and networking skills exhibited while working in cross-functional and cross-cultural teams (internal & external) and on projects Effective and influential communication, self-management, and organizational skills Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity Flexibility to adjust to altered priorities


Other Information/Additional Preferences:

Need to travel periodically to AST/ ISST/Investigator Engagement meetings and potentially other scientific or regional symposiums Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying. 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.

#WeAreLilly

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.

#WeAreLilly

  • Associate / Sr. Associate - Clinical Trial Supply Management

    5 months ago

    Cork, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, 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 41,000 employees around the world work to discover and bring life-changing medicines...

  • Planner | Exectuive Planner | Senior Planner | Associate

    1 month ago

    Cork, Ireland Penguin Recruitment Full time

    Job Title: Planner | Executive Planner | Senior Planner | AssociateLocation: Cork or DublinThe Company:Penguin recruitment is delighted to be supporting one of Irelands largest planning consultancies, with offices in Dublin and Cork, that is seeking motivated Town Planners from Planner up to Associate level. As one of Ireland's largest consultancies, the...

  • Senior Associate, Fund/Client Accounting

    5 months ago

    Cork, Ireland THE BANK OF NEW YORK MELLON CORPORATION Full time

    Senior Associate - Fund/Client Accounting At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly % of the world’s investible assets. Every day around the globe, our ,+ employees bring the power of their perspective to the table to create...

  • Associate Manager, HRBP

    2 months ago

    Cork, Ireland Stryker European Operations Limited Full time

    Work Flexibility: Hybrid Associate Manager, HR. Stryker Model Farm Road Permanent & Hybrid Working Position Summary: This position is responsible for executing the talent strategy, providing a consistent experience to managers and employees and supporting and executing the engagement strategy. The Associate HR Manager provides HR...

  • Associate Director, Supply Planning

    6 months ago

    Cork, Ireland BioMarin Full time

    Associate Director of Supply Planning BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often...

  • Associate/Snr Associate

    6 months ago

    Cork, Ireland Lilly Full time

    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...

  • Associate Project Manager

    3 weeks ago

    Cork, Ireland AECOM Full time

    Job DescriptionStart here. Grow here.  At AECOM, we are recruiting an Associate Project Manager to join us in our Cork or Galway office.Here’s what you’ll do: Your day-to-day will include but not be limited to the following tasks and responsibilities;•  Recent experience in project delivery of RIBA Stages 0 to 7 is required.• Manages one or more...

  • Associate/Senior Associate

    6 months ago

    Cork, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Eli Lilly Cork, is made up of a talented diverse team of over 1,400 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical...

  • Senior Associate Lab Automation Scientist

    3 weeks ago

    Cork, Ireland Pfizer Ireland Pharmaceuticals Full time

    Why Patients Need You Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or...

  • Associate / Senior Associate - Clinical Trial Digital Solution Delivery

    5 months ago

    Cork, Ireland Lilly Full time

    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...

  • Senior Associate

    6 months ago

    Cork, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, 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 41,000 employees around the world work to discover and bring life-changing medicines...

  • Associate / Senior Associate - Trial Capabilities, Contracts and Budgets - German Speaking

    5 months ago

    Cork, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, 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 41,000 employees around the world work to discover and bring life-changing...

  • Associate Director

    3 months ago

    Cork, Ireland AtkinsRéalis Full time

    Job Description AtkinsRéalis Ireland is seeking a dynamic and experienced Associate Director to join our thriving Bridge Design Team in Cork . With a substantial portfolio of secured projects and a robust pipeline of exciting ventures, this role offer an outstanding opportunity for career advancement. The successful candidate will have the...

  • Senior Technical Manager, Supplier Quality Management

    6 months ago

    Cork, Ireland BioMarin Full time

    Who We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...

  • Associate / Senior Associate - Global Scientific Communications - Publications

    6 months ago

    Cork, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. At Lilly, we make a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that we do are our talented and motivated professionals, circa 850 of whom...

  • Associate / Sr Associate - Regulatory Labeling

    6 months ago

    Cork, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. About Lilly At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines...

  • Associate - Project Management

    5 months ago

    Cork, Ireland CFC S.A. (CFCL) Full time

    Field of Activity In your new position in Client Readiness Stream of Pole Project, you will support the Stream Lead across a wide range of tasks related to client migration from other Clearstream entities to CFCL You will also work closely with different functional areas of DBG entities and external consultants to achieve the project’s goals.  Primary...

  • Senior Associate/Manager

    6 months ago

    Cork, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical...

  • Associate Director, Health Literacy Patient Engagement, CDDA

    5 months ago

    Cork, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, 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 41,000 employees around the world work to discover and bring life-changing medicines...

  • Associate / Sr Associate – Customer Excellence & Medical Solution (Spanish and Italian)

    5 months ago

    Cork, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. About Lilly Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology,...