Local Study Associate Director - Contract

WHY JOIN US?

At AstraZeneca, we are dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. With an ambitious goal of delivering 20 new medicines by 2030, there is no better place to make a difference in medicine, for patients, and in society.

Join us on this exciting journey to pioneer the future of healthcare. Our inclusive culture champions diversity and collaboration, and we are always committed to lifelong learning, growth, and development. As part of our team, you'll contribute to groundbreaking advancements that will shape a healthier future for people everywhere. Be a catalyst for change at AstraZeneca, where your work will have a real impact on improving people's lives.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

About the Opportunity:

Join our dynamic team as a Local Study Associate Director (LSAD) and lead Local Study Teams (LSTs) at the country level to deliver clinical studies within agreed resources, budget, and timelines. You will ensure compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. In addition to leading LSTs, you may perform site monitoring as needed to support our flexible capacity model. Your responsibilities will include identifying sites, performing site qualifications, setting up, initiating, monitoring, closing, and archiving documentation.

This role is virtual, and is open to candidates who reside anywhere in Canada.
 

This is a one-year contract.

Accountabilities:

• Overall responsibility for study commitments within the country and timely delivery of data to required quality.

• Lead Local Study Team consisting of CRA(s), CSA(s) for assigned study/studies.

• Optimize the performance of the Local Study Team(s) ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations.

• Ensure high-quality clinical and operational feasibility assessments of potential studies.

• Coordinate site selection by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits.

• Ensure timely submission of application/documents to EC/IRB and Regulatory Authority.

• Prepare and maintain accurate study budgets and financial agreements.

• Prepare local Master CSA and amendments as needed.

• Prepare country-level Master Informed Consent Form (MICF) and subsequent site-level ICFs.

• Collect and verify trial essential documents prior to study start.

• Plan and coordinate local drug activities.

• Set up and maintain the study in CTMS and local websites as required.

• Oversee monitoring activities from site activation through study closure.

• Review monitoring visit reports and advise monitors on study-related matters.

• Perform co-monitoring and training visits with study CRAs.

• Identify risks and facilitate resolution of complex study problems.

• Organize regular Local Study Team meetings.

• Report study progress to the Global Study Associate Director/Global Study Team.

• Contribute to patient recruitment strategy and communicate with participating Investigators.

• Develop and review risk management plans at the country study level.

• Communicate regularly with National Coordinating Investigator/National Lead Investigator.

• Plan and lead National Investigator meetings.

• Forecast study timelines, resources, recruitment, budget, study materials, and drug supplies.

• Ensure relevant systems are set up for business-critical activities.

• Ensure accurate payments related to the study are performed according to local regulations.

• Train and coach new members of the Local Study Team.

• Ensure completeness of the eTMF and readiness for inspection.

• Plan and lead activities associated with audits and regulatory inspections.

• Provide input to process development and improvement.

• Provide regular information to Line Managers on study milestones/key issues.

• Update Line Managers about the performance of CRAs/CSAs.

• Ensure compliance with local policies and code of ethics.

• Provide feedback on research-related information useful for the local market.

• Collaborate with the local Medical Affairs team.

• Support SMM in different initiatives as agreed with SMM Line Management.

Essential Skills and Experience:

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).

• Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).

• Experience in cell therapy and oncology studies.

• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.

• Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget, and with required quality.

• Excellent project management skills.

• Excellent team building and interpersonal skills.

• Excellent organizational skills.

• Excellent verbal and written communication skills.

• Excellent ability to prioritize and handle multiple tasks.

• Excellent attention to details.

• Excellent knowledge of spoken and written English.

• Good negotiation skills.

• Good ability to learn and adapt to work with IT systems.

• Ability to travel nationally and internationally as required.

Desirable for the Role:

• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.

• Good knowledge of the Drug Development Process.

• Excellent understanding of the Clinical Study Process including monitoring.

• Very good understanding of the Study Drug Handling Process and the Data Management Process.

SO, WHAT’S NEXT?

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.
 

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

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel
   

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

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.