Local Study Manager, Biopharmaceuticals (12 Month Contract)

Are you passionate about leading clinical trials and drug development? Be part of the team that follows the science to transform the lives of patients living with cancer. There is no better place to make an impact, join AstraZeneca today!

About AstraZeneca:

AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

 At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

AstraZeneca Canada:

Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 7 straight years. Our collaborative work environment fosters knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we’re working towards making a meaningful impact where society needs it — health. We know the health of people, the planet and our business are interconnected, each impacting the others.

Our dynamic culture truly sets us apart. We support our people every day, focusing on three priorities: employee growth & development, health & wellbeing, and cultivating a vibrant, engaged and energized workplace. Through practical tools, resources, inspiring learning opportunities, and health and wellness support, we are helping our people thrive at work and beyond.

Our Biopharmaceuticals Research and Development Team:

Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world’s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment. It’s a place to think differently – to find new ways of handling and treating diseases. We are trusted and empowered to explore.

What you’ll do:

• Plan and deliver local commitment of global clinical studies to the agreed time, budget and scope

• Coordinate and lead local study team meetings

• Develop or provide study related input to local and global study documents including clinical study protocols, consent forms, source data verification plans, data management plans, risk management plans and recruitment action plans

• Develop, coordinate and deliver study training for the local study team members, site monitors and possibly investigators

• Lead site start-up activities including ethics submission, informed consent review, development and finalization of clinical study agreements, site specific budget negotiations, site system set-ups, site vendor set-up, recruitment expectations, and follow-up and maintenance of all study activities

• Develop and maintain study budget, study timelines, and study resources and update tracking systems appropriately

• Coordinate data management activities, such as query resolution, SDV and timelines for final data entry

• Plan and lead activities associated with audits in liaison with clinical quality assurance.

Essentials for the role:

• Bachelor of Science degree in related discipline, preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields

• Experience working on clinical studies

• At least 5 years experience from within the pharmaceutical industry or similar organization or academic experience.

• Extensive knowledge of clinical operations, project management tools and processes

• Proven organizational and analytical skills

• Excellent interpersonal skills and demonstrated ability to work and lead cross-functional teams with internal and external partners

• Demonstrated Project Management skills, displaying excellent organization and time management capabilities, high attention to detail, and an ability to work in a high volume environment with shifting priorities

• High level of understanding of clinical data flow

• Excellent verbal and written communication and presentation skills

• Demonstrates sound knowledge of GCP, procedural documents, as they pertain to study delivery systems and processes

• Proactively identifies risks, issues and possible solutions

• Demonstrates high standards and uses tactful persuasion to obtain desired outcomes while maintaining effective, positive, organizational relationships

• Develops core knowledge of therapy areas for responsible studies

• Demonstrates professionalism and mutual respect

• Willingness to travel both domestically and internationally.

Why AstraZeneca?

This is the place to make a meaningful impact – on patients’ lives and your personal growth. It’s both rewarding and inspiring, and it’s what keeps us motivated every day.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 7 years:https://reviews.canadastop100.com/top-employer-astrazeneca-canada   
• Learn more about our culture:https://www.linkedin.com/posts/genarestivo_greatpeople-greatplacetowork-topemployers2020-activity-6608742174811049985-N-8G
• Browse AstraZeneca's YouTube channel to find out more about us: https://www.youtube.com/user/astrazeneca  

Are you interested in working at AZ, apply today!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.