Role Overview:
The Associate Director Study Manager leads the operational planning, execution, and delivery of one or more global clinical trials. Ensures high-quality study conduct, drives timelines, manages risks, and coordinates across internal and external stakeholders.
Key Responsibilities:
- Lead operational planning, feasibility assessment, and execution of assigned clinical trials
- 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)
- Oversee study timelines, key deliverables, and execution milestones
- Provide operational input into clinical trial documents (protocols, plans, reports)
- Lead governance interactions (senior management updates and cross-functional meetings)
- Coach, mentor, and develop junior staff; may serve as a subject matter expert
- Contribute to process improvements
Required Qualifications:
- Bachelor’s degree in life sciences or related field (required)
- Advanced degree (preferred)
Experience:
- Bachelor’s + minimum 9 years OR Master’s + minimum 6 years OR PhD/PharmD + minimum 2 years clinical development experience
Required Skills:
- Strong knowledge of ICH/GCP and clinical research regulatory requirements
- Ability to lead global, cross-functional clinical trial teams
- Project management, planning, and execution skills; manage competing priorities
- Advanced problem-solving and risk management
- Stakeholder engagement and influencing skills
- Excellent written/verbal communication
- Proficiency in Microsoft Office (Excel, PowerPoint, Word)
Preferred Skills:
- Experience in global clinical trial environments
- Vendor/CRO oversight experience
- Immunology or relevant therapeutic area experience
- Experience leading cross-functional governance and decision-making forums
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.