Clinical Trial Manager II

🕒 vor 1 Monat

🇵🇱 Polen – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

🧪 Wissenschaftler Klinische Forschung

👻 Geisterscore 31%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Syneos Health

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10.000+ Mitarbeiter

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Syneos Health ist eine führende, vollständig integrierte biopharmazeutische Lösungsorganisation, die darauf ausgelegt ist, den Erfolg ihrer Kunden zu beschleunigen. Sie übersetzen einzigartige klinische, medizinische und kommerzielle Erkenntnisse in Ergebnisse, um den Anforderungen des modernen Marktes gerecht zu werden. Durch die Nutzung fortschrittlicher Technologien und Erkenntnisse arbeitet Syneos Health mit Kunden zusammen, um die Bereitstellung wichtiger Therapien für Patienten weltweit zu beschleunigen, und bietet Dienstleistungen, die das gesamte Spektrum von der klinischen Entwicklung bis zur Kommerzialisierung abdecken.

Beschreibung

• Collaborates with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plans logistics and resource usage. • Tracks study progress in alignment with project milestones, client deliverables, and budget, and follows applicable regulations globally and by region. • Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. • Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters. • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. • Participates and presents in key meetings such as Kick Off Meeting. • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.

🎯 Anforderungen

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience • Demonstrated ability to lead and align teams in the achievement of project milestones • Demonstrated capability of working in an international environment. • Demonstrated expertise in site management and monitoring (clinical or central) • Preferred experience with risk-based monitoring • Demonstrates understanding of clinical trial management financial principles and budget management • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Must demonstrate good computer skills • Strong conflict resolution skills • Demonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project. • Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues

🏖️ Vorteile

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself.