Global Project Manager

🕒 vor 10 Tagen

🇬🇧 Vereinigtes Königreich – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

👷‍♀️ Projektmanager

👻 Geisterscore 12%

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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Clinilabs

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2000

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Clinilabs ist eine globale Full-Service-Auftragsforschungsorganisation (CRO), die sich auf die Entwicklung von zentralen Nervensystem (ZNS) Medikamenten, Geräten und Technologien spezialisiert hat. Das Unternehmen bietet umfassende Dienstleistungen für Pharma-, Biotechnologie- und Medtech-Unternehmen an und unterstützt deren Projekte von der Erstanwendung am Menschen bis zu klinischen Phase-3-Studien. Clinilabs hat sich der Bewältigung der erheblichen ungedeckten Bedürfnisse in der ZNS-Arzneimittelentwicklung verschrieben, mit Fokus auf neurologische, psychische und Substanzgebrauchsstörungen.

Beschreibung

• Oversee, lead, and coordinate cross-functional operational aspects of global and multi-regional clinical projects from protocol concept through final clinical study report • Ensure client goals for time, cost, quality, client satisfaction, operational delivery, ICH-GCP compliance, regulatory requirements, and SOP adherence • Prepare and implement global project plans, including Integrated Quality Management Plans and Risk Management Plans • Ensure site facilities and staff are adequate for global clinical trial demands • Review and provide input to clinical trial protocols and align the clinical monitoring team on protocol-related activities • Review, approve, and implement strategies, policies, and standard operating procedures • Attend investigator meetings, governance committees, and other clinical research meetings as needed • Develop and support annual budgets, billability levels, revenue targets, and expense targets • Ensure CNS rating scale quality control and standardization through rater training and monitoring • Develop proposals in response to pharmaceutical and biotech RFPs; support bid-defense slide development and attend bid defenses • Serve as the primary operational contact with sponsors regarding study conduct, timelines, quality, risks, financial performance, and budgets • Allocate study resources, including outsourcing and vendor identification, and manage resource needs across global regions • Oversee global feasibility, regulatory submissions, country/site activation, start-up metrics, and site greenlight status • Provide strategic leadership and oversight to the Clinical Manager and clinical monitoring team • Review monitoring trends, non-compliance issues, and critical site deviations • Develop project documentation and ensure study plans are delivered on time by cross-functional leads • Track, manage, and report project and overall trial budgets • Oversee site selection, initiation, and start-up activities • Oversee interim study conduct, recruitment and enrollment, safety issues, SAE tracking, study drug supply, and monitoring report review • Identify resource or progress gaps, drive risk management, and formulate corrective action plans • Communicate study progress and key milestones, including FPI, LPV, DBL, CSR, and TMF metrics • Coordinate study close-out, data-query resolution, and database lock • Oversee document storage and maintain audit readiness for internal quality audits and regulatory inspections • Perform other duties as assigned

🎯 Anforderungen

• At least a bachelor’s degree; Master’s preferred in Life Sciences, Pharmacy, Nursing, or a related scientific field • Approximately 5 to 7 years of direct clinical research project management experience in a CRO or pharmaceutical environment • Project management experience and skill in developing study procedures and processes • Proven track record managing complex, multi-region, global clinical trials across at least 2 regions simultaneously • Extensive operational experience leading CNS trials, such as Alzheimer’s, Parkinson’s, Epilepsy, Depression, Schizophrenia, Multiple Sclerosis, or rare neurodevelopmental disorders • Strong understanding of CNS endpoints, rater variability challenges, and strategies to mitigate the placebo effect in psychiatric and neurological trials • Demonstrated knowledge of the overall drug development process, including study initiation, clinical monitoring, Data Management, biostatistical output, drug safety, regulatory issues, and report generation • Proficiency with ICH/GCP guidelines, FDA, EMA, local regulations, CTMS, EDC, eTMF, and project management tools such as MS Project • Excellent verbal and written communication, organizational, time-management, customer service, and interpersonal skills

🏖️ Vorteile

• Global travel may be required per study requirements • Professional development and process improvement involvement