Site Activation Manager – Oncology

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🕒 vor 1 Tag

🇵🇱 Polen – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

👔 Manager

👻 Geisterscore 25%

infoinfo

🗣️🇺🇸🇬🇧 Englisch erforderlich

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Lifelancer

51 - 200 Mitarbeiter

Gegründet 2020

💼 Beratung

🏥 Gesundheitswesen

📦 Logistik

💰 Pre Seed Round im 2022-03

Consulting • Healthcare • Logistics

Lifelancer ist eine KI-gestützte Talentvermittlungsplattform, die Arbeitgeber mit qualifizierten Fachleuten im Bereich Life Sciences, Pharmazie und IT verbindet. Die Plattform ermöglicht es Einzelpersonen, Profile zu erstellen, die ihre Fähigkeiten zeigen, mit gut bezahlten internationalen Jobs oder Projekten zusammenzubringen, und erleichtert Arbeitgebern die Einstellung und Gehaltsabrechnung in mehreren Ländern. Die Plattform zielt darauf ab, den Einstellungsprozess durch effizientes KI-Sourcing und Unterstützung bei der Einhaltung von Vorschriften zu optimieren.

Beschreibung

• 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 • Support risk assessment and issue resolution • Ensure site activation activities are appropriately 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 as needed • Ensure compliance with SOPs, ICH GCP, and applicable regulatory requirements • Provide pre-award site activation input into proposal text and budget items as needed • Coordinate and oversee site identification, essential document collection, and investigator and site contract status • Report to a senior member of the Site Activation leadership team within the assigned therapeutic area

🎯 Anforderungen

• Minimum four-year degree or nursing degree 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 • Strong leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing • Strong interpersonal, oral, and written communication skills • Ability to collaborate across the business • Team-oriented work style • 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 FDA/EU Clinical Trials Directives/National regulations, including CTAs, Amendments, Urgent Safety Measures, and End of Trial Notifications • Proficiency in Microsoft Word, Excel, and PowerPoint • Digital systems aptitude • Ability to work in a fast-paced, deadline-oriented, changing environment

🏖️ Vorteile

• 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 • Diverse and inclusive work environment • Collaborative and supportive teams • Accessible leadership • Exceptional employee experiences • Remote work arrangement

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