Site Activation Manager – Oncology

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

📋 Description

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

• Supervise cross-functional site activation efforts to meet milestones promptly and within budget.

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

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

• Convey site activation status, risks, and mitigation strategies to sponsors, project leadership, and internal teams.

• Create and maintain site activation project plans.

• Assist in risk assessment and issue resolution processes.

• Ensure proper budgeting for site activation activities.

• Monitor and manage out-of-scope work through change control procedures.

• Promote continuous improvement through the development of SOPs, best practices, metrics, and departmental initiatives.

• Support business development, proposal creation, and bid defense efforts.

• Coordinate with internal stakeholders and external vendors, addressing issues as necessary.

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

• Provide pre-award input regarding site activation for proposal text and budget items when needed.

• Oversee site identification, essential document collection, and the status of investigator and site contracts.

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

⛳️ Requirements

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

• At least 4 years of experience in a CRO in Study Start-Up with country lead or management experience is essential.

• Strong proficiency in cross-cultural communication.

• Excellent command of both spoken and written English.

• Exceptional leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing activities.

• Strong interpersonal, oral, and written communication abilities.

• Capacity to collaborate effectively across the organization.

• A team-oriented work approach.

• Comprehensive understanding of regulatory processes and guidelines.

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

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

• Proficient in Microsoft Word, Excel, and PowerPoint.

• Aptitude for digital systems.

• Ability to thrive in a fast-paced, deadline-driven, and evolving environment.

🏝️ 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 any other class protected by applicable law.

• A diverse and inclusive work environment.

• Collaborative and supportive team dynamics.

• Accessible leadership.

• Exceptional employee experiences.

• Opportunities for remote work arrangements.