Site Activation Manager – Oncology

This is a fully remote position, open to applicants in Poland.

📋 Description

• Responsible for managing and delivering site activation projects within the designated therapeutic area.

• Coordinate, collaborate, and supervise site identification along with central and local EC activities for North America, including essential document collection, investigator and site contract status, and country/study-specific site activation tasks.

• Provide site activation-related contributions to proposal text and budget items as required.

• Act as the principal point of accountability for site activation and start-up activities on designated studies.

• Oversee cross-functional site activation efforts to meet milestones on schedule and within budget.

• Manage the tracking, analysis, and reporting of site activation progress and metrics.

• Collaborate with project teams on feasibility, site qualification, selection, and regulatory activities.

• Communicate site activation status, risks, and mitigation strategies to Sponsors, project leadership, and internal teams.

• Develop and maintain site activation project plans while supporting risk assessment and issue resolution.

• Ensure site activation activities are properly budgeted; track and manage out-of-scope work through change control processes.

• Promote continuous improvement by developing SOPs, best practices, metrics, and departmental initiatives.

• Contribute to business development, proposal crafting, and bid defense support.

• Liaise with internal stakeholders and external vendors, escalating issues to guarantee timely delivery.

• Ensure adherence to SOPs, ICH GCP, and relevant regulatory requirements.

• Report to a senior member of the Site Activation leadership team within the assigned therapeutic area.

⛳️ Requirements

• Strong leadership and organizational management capabilities in planning, strategizing, managing, monitoring, scheduling, and evaluating.

• Experience and contributions to initiatives involving interaction with sites and/or clients.

• Excellent interpersonal, oral, and written communication skills in a dynamic, deadline-driven environment.

• Proven ability to collaborate across the organization.

• Team-oriented approach: actively seeks and provides guidance.

• Understanding of regulatory processes and guidelines.

• Familiarity with the initiation, planning, and execution of clinical projects and overall project planning.

• Knowledge of ICH GCP Guidelines and the FDA/EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications).

• Proficient in MS Office applications including Microsoft Word, Excel, and PowerPoint; adept with digital systems.

• A minimum of a four-year degree or a nursing degree is required.

• At least 4 years of CRO experience in Study Start-Up with country lead or managerial experience is required.

• Skilled in cross-cultural communication.

• Fluent in both spoken and written English.

🏝️ Benefits

• Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other classes protected by applicable law.