Clinical Operations Manager

Band

Level3

Job Description Summary

As a Clinical Operations Manager you will provide operational and logistical support to clinical trials in Biomedical Research (BR) with focus on increased complexity and/or priority status. You will also have defined responsibilities to support the Clinical Trial Team throughout the study lifecycle and may contribute to process improvements, cross-functional collaboration, and knowledge sharing.

Job Description

Key Responsibilities:

• Provides operational and logistical support to clinical trials in Biomedical Research (BR) with focus on increased complexity and/or priority status, in compliance with Novartis processes and Good Clinical Practice (GCP).
• Perform defined activities to support the Clinical Trial Team (CTT) throughout the study lifecycle, via study assignment and/or on-demand support.
• Maintain and share up to date knowledge of ICH-GCP, external regulations, and internal procedures. Continuously enhance expertise through training and practical application of Novartis Standard Operating Procedures (SOPs) and internal policies.
• Contribute to the finalization and management of clinical, regulatory and study-related documents in scope of role such as study protocols, patient-facing documents, etc., by ensuring documents are complete, accurate, and consistent.
• Contribute and/or maintain ownership of the management and finalization of clinical, regulatory, and study-related documents such as study protocols, patient-facing documents, Clinical Study Report (CSR) appendices, etc., by providing support to draft, review, and ensure completeness, accuracy, and consistency of these documents, as needed.
• Support and/or lead 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.
• Support and/or lead external communication such as newsletter development, external meeting organization.
• Contribute to and / or may oversee other study operations support activities (e.g. on-demand operations support, Trial Master File metrics).
• Ensure accuracy and completeness of clinical trial management databases, and trial related systems (e.g. Clinical Trial Management System, Novartis Connect), providing information, timely updates and inputs, and follow up on questions as necessary. Help check for or proactively identify discrepancies and take actions to correct as necessary.
• Identify, contribute and/or lead areas for process or technology improvements regarding activities undertaken within the role.

Essential Requirements:

• • Education: A bachelor’s degree or equivalent qualification or work experience, preferably in life sciences or nursing.
• • 2+ years’ experience in clinical trial/ development
• • Adept organizational skills and quality mindset with attention to detail.
• • Strong communicator with demonstrated interpersonal skills.
• • Basic 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.
• • Ability to work in a team as well as independently if required and to manage multiple priorities.
• • Knowledge of GCP requirements.
• • Office and clinical trial software, IT computer literacy.
• Desirable requirement: 
• •    successful completion of Academy fellowship program in Cambridge, MA.

The salary for this position is expected to range between $103,600 and $192,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.Benefits & Rewards

Eeo Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$103,600.00 - $192,400.00

Skills Desired

Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences