Senior Clinical Project Manager

Key Responsibilities:

• Collaborate with colleague/customer team and Line Functions to establish realistic project timelines. Escalate any unresolved disagreements to higher management.
• Lead and manage a multidisciplinary Clinical Trial Team (CTT), ensuring effective planning, evaluation, and implementation of assigned clinical studies and programs.
• Organize and facilitate investigators meetings and internal meetings related to study execution and operational excellence.
• Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study setup and conduct, monitor site performance, address protocol deviations, and resolve issues.
• Support compilation of study regulatory documents for submissions and assist with monitoring activities and communications with partners.
• Review site visit reports and monitor activities for quality control.
• Chip in to ongoing medical/scientific data quality review and coordinate data analysis and interpretation for first results.
• Assist in developing study protocols, treatment plans, informed consent forms, and other essential study documents.
• Contribute to clinical sections of regulatory documents and ensure approval from colleague/customer.
• Handle the writing or liaise with medical writing/narrative group to ensure completion of the Clinical Study Report.
• Set up and maintain the Trial Master File (TMF), Clinical Trial Management System (CTMS), and other required systems in collaboration with Clinical Operations Specialists.

Essential Requirements:

• Life Science degree or equivalent of education, training and experience
• Fluent English (oral and written)
• 10+ years of Clinical Operations experience with strong managerial experience in planning, driving, reporting and publishing clinical studies (interventional and non-interventional, early to late phase) in a pharmaceutical
• Confirmed ability to work independently, to lead a multidisciplinary cross-functional team in a complex matrix environment (including remote).
• Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process.

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.