Senior Associate - Clinical Trial Project Management, Exploratory Medicine

About the role

Lilly's Global Business Solutions centre in Little Island, Cork, is hiring a Senior Associate for Clinical Trial Project Management in exploratory medicine. The role leads the cross-functional study team in developing and running clinical trials, delivering them on time, within scope and budget, and is accountable regionally and globally. It is open to internal applicants who meet the minimum qualifications and hold work authorization in the country of the position.

Key responsibilities

• Manage the scope, timeline, risks and budget of clinical trials, and coordinate the cross-functional study team through implementation, execution and closure
• Own the regional enrollment strategy and execution, from country allocation through Last Patient Entered Treatment, and partner with Regional Operations to meet regional enrollment goals
• Act as single point of contact for trial communications with the CPM organization, Regional Clinical Operations and third-party organizations, and manage TPO qualification, selection and oversight
• Lead the Trial Master File and ensure it stays current and inspection-ready
• Prepare and consult on clinical and regulatory documents, support regulatory agency meetings, and advise on clinical trial design, feasibility and implementation
• Apply GCP and Lilly standards, liaise with affiliates on local regulatory requirements, and coach peers and TPOs on the clinical trial process

Required profile

• Bachelor's degree (scientific or health-related field preferred) and 3 years of clinical research or relevant experience, or an advanced degree
• Preferred: exploratory and biopharmaceutics clinical development experience, and at least 3 years of clinical trial experience with a strong working knowledge of the clinical research process
• Preferred: prior clinical trial site-level or affiliate experience
• Ability to travel, up to 10%

Required skills

• Project management methodology, processes and tools (e.g. Critical Chain, ProChain Enterprise, MS Project, MS Excel, MS PowerPoint)
• Ability to work cross-culturally with global colleagues and TPOs, and to influence without authority
• Strong leadership, networking, communication and problem-solving skills

What we offer

• Anticipated wage of EUR 39,750 - 87,560, depending on education, experience, skills and location
• Pension plan, vacation benefits, healthcare benefits, flexible benefits, life insurance and death benefits, and well-being benefits
• Weekly manager 1:1s, a learning and development service and educational assistance schemes
• Flexible working options, subsidised canteen, travel subsidies and on-site parking