Senior Clinical Operations Manager

Job Description Summary

Provide or supervise operational and logistical support to clinical trials in Biomedical Research (BR) with focus on high complexity and/or priority status. Oversee junior colleagues’ activities related to study operations. Acts as a subject matter expert and/or cross-functional liaison.

Job Description

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 of

  
  
  

  people, including global teams, different cultures, diverse

  
  
  

  experience backgrounds, etc.

  
  
  

Skills Desired

Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Data Analysis, Data Integrity, Learning Design, Lifesciences, Risk Monitoring, Trends Analysis