Novartis Pharmaceuticals Senior Study Operations Manager, Clinical Sciences & Innovation in Cambridge, Massachusetts
7000 patients, 1200 clinical sites, 40 countries, 100+ clinical studies led by Novartis Clinical Sciences & Innovation (CS&I) last year.
CS&I is a group of driven Clinical Scientists who plan and execute Novartis’ early phase global clinical trials. From First-in-Human, to Proof-of-Concept, and beyond, we design and operationalize trials, ensuring they run efficiently, on time and, most importantly, with patients’ interests in the forefront. We play a pivotal role in transitioning discovery research to clinical practice.
As member of our team, you will lead, coordinate and/or oversee activities across multiple CS&I functions (e.g. clinical trial leadership, operational excellence, clinical strategy, operational feasibility, patient engagement). You will majorly contribute to high complexity and priority results in study operations (e.g. registration critical trials, Proof of Concept studies).
You will have a major impact on high quality clinical studies, collaborate across our global network, partner with best-in-class physicians and scientists, be curious, innovative and inspiring. This role also offers line management opportunities.
What You'll be doing:
• Provide operational and logistical support across CS&I for clinical trials in Translational Medicine (TM) with focus on increased complexity and/or priority status and provide direction and oversight to activities related to study operations support by functioning as regional and / or global lead to ensure quality and consistency in daily operations.
• Responsible for the oversight of vendor activities.
• Represent CS&I on cross-functional and divisional initiatives and workstreams on area(s) of expertise (e.g. process specialist).
• Lead aspects of information management for Study Operations (e.g. creation and maintenance of counsel, dashboards, trainings), contained on the intranet and in general trainings.
• Provide line management of junior associates in trainee programs (up to 8 staff members) and day to day oversight of other personnel as needed. Oversee and support the professional development of assigned associate(s), and ensure quality work and compliance with Novartis processes
• Lead management of clinical, regulatory and study-related documents such as study protocols, plain language trial summaries, etc. by ensuring timely review and completion within the study operations team.
• Lead interactions and communications with investigator sites and local Novartis trial teams as needed during feasibility assessments and / or during clinical trial operation.
• Oversee to ensure accuracy of clinical trial management databases, systems, and resource/budget tracking tools, providing information and following up on questions as requested. Ensure timely and regular updates to CTMS and other key information repositories.
Senior Study Operations Manager, Clinical Sciences & Innovation
What you’ll bring to the role:
• A Bachelor’s degree or equivalent qualification or work experience, preferably in life sciences or nursing.
• 5+ years of experience in clinical trials (e.g. clinical trial planning and set up, execution, and operations) is required.
• Project management experience evidenced by the ability to coordinate optimally and deliver results.
• Adept organizational skills and quality mentality with attention to detail.
• Effective and proactive communication skills (verbal and written).
• Well-developed interpersonal skills with ability to build rapport, manage, and mentor others.
• Proven presentation skills and ability to mentor / train small groups
Why consider Novartis?
799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Research & Development
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.