Senior Clinical Operations Manager

Novartis; Hyderabad; On-site; INR 1,200,000 - 1,500,000; Full time

Job summary

Novartis in Hyderabad, India seeks an experienced clinical trial operations professional to support global trials and contribute to study outcomes. You will oversee junior colleagues and act as a subject matter expert and cross-functional liaison.

You will provide operational and logistical support to high-complexity trials, ensure GCP compliance, manage study documents, and share knowledge to strengthen internal processes. Mentoring and cross-team collaboration are key.

Qualifications

• 5–7 years of experience in clinical trial development.
• Project management experience with proven delivery of results.
• Adept organizational skills and attention to detail.
• Effective verbal and written communication; proactive.
• Strong interpersonal skills to build rapport and coach others.
• Solid presentation skills and ability to mentor/train small groups.

Responsibilities

• Provides operational and logistical support to clinical trials with focus on high complexity and priority status, in compliance with GCP.
• Perform or supervise activities to support the Clinical Trial Team throughout the study lifecycle.
• Maintain and disseminate up-to-date knowledge of ICH-GCP, external regulations, and internal SOPs.
• Lead finalization and management of study documents such as CSR appendices and patient-facing materials.
• Lead or oversee interactions with relevant functions including country organizations to prepare and follow up on actions.
• Lead or oversee external communication and other study operations support activities.

Skills

Clinical trial experience

Project management

Communication skills

Leadership / mentoring

Attention to detail

Interpersonal skills

Budget management

Clinical Research

Clinical Trials

Coaching / training

Data Analysis

Data Integrity

Risk Monitoring

Job description

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