Study Activation Manager
HybridRaleigh, North Carolina, United States
Job Summary
Develop and lead global study start-up and site activation strategy, including sequencing, critical path dependencies, and mitigation plans. Establish and communicate activation plans aligned with sponsor expectations, timelines, and core team priorities while serving as the primary operational point for status, risks, escalations, and recovery planning. Partner with Feasibility, Clinical Operations, Regulatory Affairs, Site Contracts, and Budgets leads to support site identification, submission planning, contract monitoring, and milestone alignment. Monitor activation metrics, dashboards, and project tracking systems to assess progress, data quality, and delivery commitments, ensuring accurate reporting for sponsor updates and executive governance. Identify and escalate start-up risks related to delayed sites, document collection, and resource constraints while ensuring activities comply with ICH, GCP, and CTI SOPs. Prepare and approve status reports, present updates during sponsor and internal meetings, and drive process improvements to strengthen operational consistency and sponsor confidence.
Required Qualifications
- Experience leading global study start-up and site activation activities across multiple trials, countries, and functional partners
- Strong understanding of global, country and site activation strategy, start-up dependencies, critical-path management, and milestone forecasting
- Ability to interpret start-up metrics, identify risks or trends, and drive timely mitigation, escalation, and recovery planning
- Excellent verbal and written communication skills, including experience presenting risks, decisions, and recommendations to senior internal leaders and sponsor teams
- Ability to influence and align cross-functional stakeholders without direct authority
- Ability to build strong client, peer, and cross-functional relationships through effective interpersonal and leadership skills
- Ability to manage multiple trials, priorities, and sponsor deliverables accurately and efficiently
- Strong organizational, documentation, record retention, and time management skills
- Strong decision-making, critical thinking, and solution-focused problem-solving skills
- Demonstrated accountability, follow-through, and ability to manage shifting priorities in a fast-paced clinical trial environment
- Strong knowledge and clear understanding of CTI SOPs, sponsor requirements, ICH/GCP guidelines, and applicable regulatory requirements
- Ability to clearly articulate site start-up and activation processes, SOPs, regulatory pathways, TMF expectations, and related procedures
- Proficiency with clinical trial management systems, start-up tracking tools, and standard business software systems
- Bachelor's degree in a scientific, health care, or related discipline, or equivalent experience
- 8 years of clinical research experience, including significant experience in study start-up, site activation, clinical operations, or clinical trial management
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