Site Activation Manager

Worldwide Clinical Trials•Research Triangle Park, NC

5d•$86,000 - $170,000

About The Position

Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries and innovates to find cures for diseases. They are looking for individuals who share their passion for improving lives. The Site Activation Manager is responsible for project management and delivery of site activation activities within the Oncology therapeutic area. This includes coordinating and overseeing site identification, central and local EC activities, essential document collection, monitoring contracts, and other site activation tasks in compliance with GCPs and regulations. The role may also involve pre-award support for proposals and budgets. The Site Activation Manager reports to a senior member of the Site Activation leadership team.

Requirements

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 is required
Minimum of 4 years CRO experience in Study Start-Up with country lead or manager experience required
Proficient in cross-cultural communication
Proficient in both spoken and written English

Responsibilities

Serve as the primary point of accountability for site activation and start-up activities on assigned studies.
Oversee cross-functional site activation activities to ensure milestones are achieved on time and within budget.
Manage the accurate tracking, analysis, and reporting of site activation progress and metrics.
Partner with project teams to support feasibility, site qualification, selection, and regulatory activities as needed.
Communicate site activation status, risks, and mitigation plans to Sponsors, project leadership, and internal teams.
Develop and maintain site activation project plans and support risk assessment and issue resolution.
Ensure site activation activities are appropriately budgeted, with out-of-scope work tracked and managed through change control.
Drive continuous improvement through SOP development, best practices, metrics, and departmental initiatives.
Contribute to business development activities, including proposal development and bid defense support.
Liaise with internal stakeholders and external vendors, escalating issues as needed to ensure on-time delivery.
Ensure compliance with SOPs, ICH GCP, and applicable regulatory requirements.