Band

Level 5

Job Description Summary

-Oversees the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements. Monitors adherence to protocols and determines study completion. Manages clinical and regulatory files and maintains clinical inventory intended for distribution to investigational sites

Job Description

Major accountabilities:

• Is a global clinical manager or country / cluster leader responsible for clinical program(s) across indications executing medical strategy for development and marketed products in a defined therapeutic area -Responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring.
• May be responsible for the scientific and medical strategy of assigned sections of a clinical development program.
• Contributes to the development of clinical sections of trial and program level regulatory documents -Contributes to the execution of the section of the clinical program in partnership with global line functions.
• Contributes to ensuring overall safety of the compound for assigned trial(s) in collaboration with Patient Safety.
• Supports by contributing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas -Contributes to medical/scientific training of relevant Novartis stakeholders.
• May serve as speaker for franchise medical/scientific training -Contributes to the global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) -Contributes to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Deliver customer satisfaction results for internal and external customers -Delivery of Clinical Trials to quality standards and agreed timelines -Adherence to Novartis policy and guidelines and external regulations.

Minimum Requirements:
Work Experience:

• Functional Breadth.
• Managing Crises.
• Collaborating across boundaries.

Skills:

• Clinical Trials.
• Data Analysis.
• Data Monitoring.
• Drug Development.
• Drug Discovery.
• Medical Strategy.
• People Management.

Languages :

• English.

Skills Desired

Clinical Trials, Data Analysis, Data Monitoring, Drug Development, Drug Discovery, Medical Strategy, People Management