Associate Study Management III

Posted 18hrs ago

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Job Description

Clinical study leader managing global immunology trials for AbbVie, a pharmaceutical company developing innovative medicines. Overseeing vendors, recruitment, compliance, study systems, risks, and cross-functional execution.

Responsibilities:

  • Provide study-level oversight and leadership for one or more global clinical trials from inception through closure
  • Support the Study Project Manager in strategic leadership of cross-functional teams, stakeholder engagement, strategy development, meeting facilitation, documentation, deliverables, and timelines
  • Manage external vendors, including RFPs, selection, scope of work, deliverable oversight, and risk management
  • Lead global recruitment management, strategy development, and mitigation planning from country feasibility through subject recruitment and retention
  • Lead cross-functional, vendor, and investigator meetings; prepare agendas, curate and file minutes, and provide study-status updates
  • Ensure inspection readiness and participate in related activities
  • Identify, mitigate, escalate, and manage risks and issues; support trend analysis and risk prevention
  • Co-develop and manage study materials, including protocols, regulatory submissions, patient-reported outcome measures, study execution plans, informed consent, site budgets and agreements, clinical study reports, training materials, newsletters, and stakeholder presentations
  • Manage CTMS and eTMF to support compliance, inspection readiness, trend analysis, and timelines
  • Support EDC, IRT, and ePRO design reviews, user acceptance testing, plans, key risk indicators, access support, query resolution, and system oversight
  • Manage investigational product and associated study supplies
  • Provide training to study team members, vendors, and other stakeholders
  • Support global submission strategies
  • Support process improvement initiatives or serve as a subject matter expert and/or mentor

Requirements:

  • Bachelor’s Degree or OUS equivalent required
  • At least 4 years of progressive Pharma-related/clinical research-related experience with a high level of core and technical competencies
  • Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations)
  • Experienced user of EDC, IRT, CTMS, and eTMF
  • Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and develop strategies
  • Excellent organizational and time management skills; strong attention to detail
  • Exceptional interpersonal skills and ability to communicate effectively in a clear and persuasive manner in a global setting
  • Proficient in business/technical English-language (oral and written)
  • Proactive, collaborative mindset
  • Ability to work independently in a fast-paced global team environment
  • Preferred: exposure to study initiation through completion activities; global study exposure