Associate Director Study Manager (Hybrid)

MSDSan Diego, PA
Hybrid

About The Position

The Associate Director Study Manager leads the operational planning, execution, and delivery of one or more global clinical trials. This role is accountable for ensuring high-quality study conduct, driving timelines, managing risks, and coordinating across internal and external stakeholders to meet clinical trial objectives.

Requirements

  • Bachelor's degree in life sciences or related field required
  • Bachelor's with a minimum of 9 years OR Master's with a minimum of 6 years OR PhD/PharmD with a minimum of 2 years of clinical development experience
  • Strong Knowledge of ICH/GCP and clinical research regulatory requirements
  • Proven ability to lead global, cross-functional clinical trial teams
  • Strong project management, planning, and execution skills
  • Ability to manage competing priorities and drive milestone delivery
  • Advanced problem-solving and risk management capabilities
  • Strong Stakeholder engagement and influencing skills
  • Excellent written and verbal communication skills
  • Proficiency in Microsoft Office tools (Excel, PowerPoint, Word)

Nice To Haves

  • Advanced degree preferred
  • Experience working in global clinical trial environments
  • Vendor/CRO oversight experience
  • Experience in Immunology or relevant therapeutic area
  • Experience leading cross-functional governance and decision-making forums

Responsibilities

  • Lead operational planning, feasibility assessment, and execution of assigned clinical trials(s)
  • Serve as the Clinical Trial Team (CTT) Lead and provide cross-functional leadership
  • Drive study strategy, operational reviews, and risk identification and mitigation planning
  • Collaborate with internal teams, country organizations, and external partners (e.g. CROs, vendors) to deliver study objectives
  • Oversee study timelines, key deliverables, and execution milestones
  • Provide operational input into clinical trial documents (protocols, plans, reports)
  • Lead governance interactions, including senior management updates and cross-functional meetings
  • Build team capabilities through coaching, mentoring, and development of junior staff
  • Contribute to process improvements and may serve as a subject matter expert

Benefits

  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays, vacation, and compassionate and sick days
  • annual bonus
  • long-term incentive
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