Hybrid Clinical Trial Manager – Pharma Sector

Über das Unternehmen

Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. With a rich history of innovation, Novartis focuses on discovering, developing, and marketing breakthrough medicines. Our purpose is to reimagine medicine to improve and extend people’s lives, using innovative science and digital technologies to create transformative treatments in areas of great medical need. We are committed to fostering a diverse and inclusive environment where our associates can thrive and contribute to our mission.

Stellenbeschreibung

Novartis is seeking a dynamic and experienced Hybrid Clinical Trial Manager to join our innovative team. In this pivotal role, you will be responsible for the overall operational planning, execution, and oversight of assigned clinical trials, ensuring they are conducted in accordance with ICH-GCP guidelines, regulatory requirements, and company standard operating procedures (SOPs). This hybrid position offers the flexibility of working both remotely and on-site, allowing you to engage directly with sites and internal teams while benefiting from a flexible work arrangement. You will manage cross-functional teams, monitor trial progress, and proactively identify and resolve operational challenges to ensure timely and high-quality data delivery for drug development programs. This is an exciting opportunity to contribute to life-changing therapies within a leading global pharmaceutical company.

Hauptverantwortlichkeiten

• Manage and oversee the operational aspects of assigned clinical trials from study start-up through close-out, ensuring adherence to project timelines and budget.
• Develop and implement comprehensive study plans, including monitoring plans, communication plans, and risk management strategies.
• Lead and motivate cross-functional study teams, fostering effective collaboration with internal stakeholders (e.g., Medical Affairs, Regulatory Affairs, Data Management) and external partners (e.g., CROs, investigators).
• Monitor study progress, identify potential risks, and implement proactive solutions to mitigate delays and ensure data quality.
• Conduct site visits (pre-study, initiation, routine monitoring, close-out) as required by the hybrid model, providing training and support to investigational site staff.
• Ensure all trial activities comply with ICH-GCP, local regulations, and Novartis SOPs.
• Manage vendor relationships and performance for outsourced trial activities.
• Prepare and present regular trial status reports to senior management and internal stakeholders.
• Oversee budget management for assigned clinical trials, ensuring cost-effective resource allocation.
• Participate in the selection and qualification of investigators and clinical trial sites.

Erforderliche Fähigkeiten

• Minimum of 5 years of experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industry.
• Proven track record of managing complex clinical trials across various phases (Phase I-III).
• In-depth knowledge of ICH-GCP guidelines, global regulatory requirements, and clinical trial processes.
• Strong project management skills, including budgeting, timeline management, and risk mitigation.
• Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across diverse teams.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related scientific field.
• Fluency in English (written and spoken).
• Ability to travel locally and internationally as required by the hybrid model.

Bevorzugte Qualifikationen

• Master's degree or PhD in a relevant scientific or health-related discipline.
• PMP certification or equivalent project management qualification.
• Experience with a variety of therapeutic areas.
• Proficiency in German.

Vorteile & Zusatzleistungen

• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness programs.
• Generous paid time off and flexible work arrangements.
• Opportunities for professional development and career advancement.
• Employee stock purchase plan.
• Pension scheme and life insurance.
• Access to innovative research and development projects.
• A diverse and inclusive work environment.

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