Site Activation Manager
$86,000–$170,000 year
On-siteDurham, North Carolina, United States
Job Summary
Coordinate site activation project management and delivery for Oncology studies, overseeing site identification, central and local EC activities, and essential document collection. Monitor investigator contracts, manage proposal text and budget inputs for pre-award support, and ensure compliance with GCPs and regulatory requirements. Oversee cross-functional activities to achieve milestones on time and within budget, tracking progress metrics and communicating risks to sponsors and leadership. Develop project plans, support feasibility and qualification activities, and drive continuous improvement through SOP development and best practices. Liaise with internal stakeholders and external vendors to ensure on-time delivery while managing out-of-scope work through change control.
Required Qualifications
- Strong leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing
- Ability to provide experience and input into initiatives relating to interacting with sites and/or customers
- Strong interpersonal, oral and written communication skills in a fast-paced, deadline-oriented, and changing environment
- Demonstrated ability to collaborate across the business
- Team-oriented work style: seeks and gives guidance
- Understanding of regulatory processes and guidelines
- Understanding of initiation, planning, and execution of clinical projects and overall project planning
- Awareness of ICH GCP Guidelines and the FDA/EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)
- Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude
- A minimum four-year degree or nursing degree
- Minimum of 4 years CRO experience in Study Start-Up with country lead or manager experience
- Proficient in cross-cultural communication
- Proficient in both spoken and written English
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