Senior Clinical Operations Manager

Major accountabilities:

• Provides operational and logistical support to clinical trials in Biomedical Research (BR) with focus on high complexity and/or priority status, in compliance with Novartis processes and Good Clinical Practice (GCP).
• Perform or supervise defined activities to support the Clinical Trial Team (CTT) throughout the study lifecycle, via study assignment and/or on-demand support.
• Maintain, share, and actively disseminate up-to-date knowledge of ICH-GCP, external regulations, and internal procedures. Continuously strengthen expertise through training and practical application of Novartis Standard Operating Procedures (SOPs) and internal policies.
• Lead finalization and management of clinical, regulatory and study-related documents in scope of role such as study protocols, patient-facing documents, etc.
• Responsible for ownership and leading the preparation of in-scope study documents, e.g. Clinical Study Report (CSR) appendices, patient-facing documents, protocol training material, etc.
• Lead or oversee interactions and communications with relevant functions including Novartis country organizations to prepare, collect, and/or compile relevant documents, and timely follow-up on pending actions as necessary.
• Lead or oversee external communication, such as newsletter development, external meeting organization.

Key performance indicators:

• Timely, efficient and quality execution of trial related activities in compliance with Novartis processes and GCP.
• Proactive operational planning with effective contingency and risk mitigation plans.
• High quality contributions to study or submission documents (i.e. study protocols, patient-facing documents)
• Strong leadership skills to be able to support management in team competency building, lead/contribute to local/global initiatives and best practice sharing across programs and/or departments -Clearly demonstrates Novartis Values and Behaviors (i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity.

Minimum Requirements:

• At least 3 to 4 years’ experience in clinical trial /development
• Project management experience evidenced by the ability to organize effectively and deliver results. Adept organizational skills and quality mindset with attention to detail.
• Effective communication (verbal and written); proactive communication skills.
• Well-developed interpersonal skills with the ability to build rapport, manage, and coach others. Solid presentation skills and ability to mentor / train small groups.
• Ability to successfully interact with a wide range ofpeople, including global teams, different cultures, diverseexperience backgrounds, etc.