SSO Clinical Project Manager

📋 Description

• Responsible for the daily planning, implementation, and reporting of assigned Global Drug Development (GDD) studies.

• Assists SSO Study Start-up Managers in creating study execution plans and timeline commitments for country/cluster/hub.

• Proactively identifies risks and opportunities related to the assigned studies within the country/cluster/hub and formulates appropriate mitigation strategies.

• Oversees the study's progress to ensure all operational aspects are proceeding as planned.

• Ensures that recruitment targets are achieved and monitors enrollment at the site level.

• Manages local study team activities to ensure adherence to study timelines and quality execution.

• Maintains oversight of data management activities at the country/cluster/hub level.

• Facilitates the study handover process with CRAs and their supervisors.

• Conducts or organizes training as required for CRAs to ensure site readiness for recruitment and study execution.

⛳️ Requirements

• A minimum of a bachelor's degree in a scientific or health-related field.

• Proficient in both written and spoken English.

• At least 5 years of experience in clinical research with expertise in overseeing project management and/or monitoring clinical trials.

• Ability to lead in a matrix environment without direct reports while managing global studies across various countries.

• Comprehensive understanding of all facets of clinical drug development, particularly focusing on monitoring and study execution.

• Strong project management skills with a proven ability to solve problems and mediate complex issues.

• In-depth knowledge of the international drug development process, including familiarity with international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations, and Novartis standards.

• Proven negotiation and conflict resolution abilities both internally and externally (site relationships).

🏝️ Benefits

• Health insurance.

• Life and disability benefits.

• 401(k) with company contribution and matching.

• Generous time-off package, including vacation, personal days, holidays, and other leaves.