UK Study Operations Manager

Aug 17, 2021
United Kingdom

Job Description

This role will be responsible for driving and managing local studies (NIS, LIS, RWE, IITs, RCs and non-clinical IIRs) in collaboration with relevant RWE managers and medical associates to ensure project delivery to time and budget. It will provide operational leadership ensuring project outputs are robust and delivered to quality for all local studies, including vendor qualification and oversight.

Your responsibilities:
Your responsibilities include, but are not limited to:
• Provide internal operational project management in the set-up, contracting, vendor qualification, maintenance and completion of IITs/Non-Clinical IIRs/RCs by working with multi-functional teams
• Ensure adherence to Global and Local SOPs, internal approval processes, internal and external governance frameworks and regulations (e.g., Novartis P3 principles, GCP, GVP, GMP and ABPI Code of Practice)
• Manage study budget, including finance systems, forecasting and oversight of the budget related to agreed milestones in the contract and provision of drug related costs
• Ensure safety reporting obligations are met, including PASS/ PAES assessment and also relevant systems are up to date with information and essential documents (e.g., Clinical Trial Management system, Document Management System and other global/local systems as relevant)
• Work with procurement, Legal, QA to set up 3rd party vendors performing UK studies, including vendor qualification
• Provide operational leadership and project management for local studies in collaboration with relevant medical associates and other multi-functional teams as applicable
• Responsible for project planning, set-up, ongoing management and study timelines. Communicate critical path and provide solutions to ensure project stays on track

Minimum Requirements

What you’ll bring to the role:
• Bachelors’ or Masters’ degree or equivalent in Science
• Experience in the set-up, management and conduct of interventional and non-interventional clinical studies.
• Previous experience in Pharmaceutical Industry preferred
• Knowledge of operational management of conducting studies to time, budget and quality
• Strong ability in project management

Desirable requirements:
• Clinical study knowledge of GxPs (GCP, GvP, GMP) and regulatory requirements
• Ability to work in matrix environments

You’ll receive:

Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. 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!

For the Eighth consecutive year, Novartis been certified a ‘Top Employer’ in the UK (2014-2021)!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

We are Novartis. Join us and help reimagine medicine.
#LI-NOV = Novartis
United Kingdom
Research & Development
Full Time
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UK Study Operations Manager

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