Clinical Project Manager

Key Responsibilities:

• Collaborate with colleagues, customers, and line functions to establish realistic project timelines. Escalate issues to higher-level management if no agreement can be reached.
• Lead and manage a multidisciplinary cross-functional Clinical Trial Team or support the Senior Clinical Project Manager in planning and implementing clinical studies and programs.
• Organize investigators meetings and internal meetings related to clinical study execution.
• Interact directly with investigator sites, CRAs, CROs, and vendors to ensure smooth study set-up and conduct, monitor site performance, address protocol deviations, and resolve issues.
• Assist in the compilation of regulatory documents for submissions to authorities and ethics committees.
• Review site visit reports and ensure quality control of monitoring activities.
• Contribute to ongoing medical/scientific quality review of study data and coordinate data analysis and interpretation for initial results.
• Contribute to the development of study protocols, amendments, informed consent forms, and other essential documents.
• Manage study budgets and provide input for clinical outsourcing specifications.
• Identify areas for process or technology improvements and participate in continuous improvement initiatives.

Essential Requirements:

• Bachelor's degree or higher in life sciences or a related field, or equivalent combination of education, training, and experience.
• Approximately 8 years of experience in Global Clinical Operations, with managerial experience in designing, planning, executing, reporting, and publishing clinical studies, both interventional and non-interventional, across different phases.
• Proven ability to work independently in a complex matrix environment, including leading cross-functional teams.
• Strong project management skills.
• In-depth knowledge of Good Clinical Practice (GCP), clinical study design, statistics, regulatory processes, and the global clinical development process.
• Excellent spoken and written English.
• Excellent presentation and diplomacy skills, with the ability to negotiate and resolve conflicts.

Desirable Requirements:

• Ability to independently resolve issues and know when to escalate them
• Accountable and responsible in project and study management.

Benefits and rewards: Monthly pension contribution matching your individual contribution up to 3% of your gross monthly base salary; Risk Life Insurance (full cost covered by Novartis); 5-week holiday per year ; 4 paid sick days within one calendar year in case of absence due to sickness without a medical sickness report; Cafeteria employee benefit program – choice of benefits from Benefit Plus; Meal vouchers in amount of 105 CZK for each working day (full tax covered by company); MultiSport Card et al. Find out more about Novartis Business Services: https://www.novartis.cz/

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.