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