Senior Clinical Operations Manager

Senior Clinical Operations Manager

Job Description Summary

-Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team, contributes to operational excellence through process improvement and knowledge sharing and/or provide inputs to clinical development process. 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.

• Lead or oversee other study operations support activities (e.g. on-demand operations support, Trial Master File metrics).

Minimum Requirements:

• At least 5 to 7 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.

Skills Desired

Budget Management, Clinical Research, Clinical Trial Protocols, Clinical Trials, Coaching, Data Analysis, Data Integrity, Learning Design, Lifesciences (Inactive), Risk Monitoring, Trend Analysis

Experience Level

Senior Level