Site Activation Manager – Oncology

🔥 0 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Accountable for site activation project management and delivery activities within the assigned therapeutic area • Coordinate, collaborate on, and oversee site identification and central and local EC activities for NA countries, essential document collection, investigator and site contract status, and country/study-specific site activation tasks • Provide site activation-related input into proposal text and budget items as needed • Serve as the primary point of accountability for site activation and start-up activities on assigned studies • Oversee cross-functional site activation activities to achieve milestones on time and within budget • Manage tracking, analysis, and reporting of site activation progress and metrics • Partner with project teams on feasibility, site qualification, selection, and regulatory activities • 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 budgeted; track and manage out-of-scope work through change control • Drive continuous improvement through SOP development, best practices, metrics, and departmental initiatives • Contribute to business development, proposal development, and bid defense support • Liaise with internal stakeholders and external vendors, escalating issues to ensure on-time delivery • Ensure compliance with SOPs, ICH GCP, and applicable regulatory requirements • Report 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 • 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

🏖️ 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 class protected by applicable law