Site Activation Manager - Europe/US

Worldwide Clinical Trials • Durham, NC

7h

About The Position

The Site Activation Manager is accountable for site activation project management and delivery activities within the Oncology therapeutic area. Responsibilities include coordination, collaboration, and oversight of site identification and central and local ECs (for NA countries only) activities, progression of essential documents collection, monitoring of investigator and site contracts status, and any other country and/or study-specific site activation tasks necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). May also include pre-award support by providing site activation-related input into the proposal text and budget items. Reports to a senior member of the Site Activation leadership team within the assigned therapeutic area.

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
• 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level