Site Management and Monitoring (SMM) Oncology Lead - Canada
Regular, full-time position
We seek a strong leader excited to implement Oncology clinical trials in-country. The growing AstraZeneca (AZ) Oncology portfolio delivers global clinical trial projects recruiting many thousands of patients every year in countries across the world.
The Site Management and Monitoring (SMM) Oncology Lead is responsible for delivering the oncology clinical interventional studies in their country. Your team will deliver studies according to agreed resources, budget and timelines following AstraZeneca's Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations.
You will be accountable for the performance of the sites selected; ensuring that Oncology study sites are identified, qualified and monitored according to AZ SOPs.
This role sits within our Late Oncology Clinical Operations team, part of our broader Oncology Research & Development organization. This team is responsible for the program and study management of clinical projects designed to generate clinical evidence in support of a registrational strategy. Therapeutic expertise in oncology, project management capability and effective leadership of cross functional teams are critical capabilities that exist within the group to ensure strategic plans are translated into action.
You are a member of the Oncology SMM Leadership Team and communicate to the Global Head any risk to study performance, feasibility assessment, enrolment and mitigation of risk to delivery of the programs. This role requires close partnership with the Country Head SMM (CHSMM) who holds country level responsibilities (e.g. legal, regulatory responsibilities) and ensures a “one SMM community”. It is also expected that in this capacity, you may contribute to local/regional/global work tasks as delegated.
- Leadership of dedicated oncology group, building the team spirit, mentoring and developing team, empowering action and style and prepares salary and bonus proposals for all team members based on their performance
- Ensures resources for the oncology studies and workload is distributed appropriately to team members
- Contributes to efficient SMM organisation and its functioning at country level building forward-thinking plans, working closely with the CHSMM
- Supports high-quality feasibility work and delivery of established country enrolment projections
- Is responsible for successful delivery country level targets to plan, with speed and quality (includes supporting the local implementation and optimisation of AstraZeneca’s digital strategy)
- Contributes to the quality improvement of study processes and other procedures
- Ensures all systems are continuously updated
- Ensures completeness and timeliness of the eTMF to be “Inspection Ready” at all times
- Provides direction to LSM/teams on major study commitments advising onstudy feasibility, forecasting study timelines, resources, recruitment, study materials and drugs including resolving any key issues identified
- Ensures positive relationships and collaboration with local Medical Affairs team
Ensures study activities within country follow local policies and code of ethics
- Bachelor’s degree preferably in life science, or equivalent qualification (*).
- Minimum 7 years of experience in Development Operations (CRA / Sr. CRA / LSM/ADSMM) or other related fields
- Strong technical and extensive clinical operations experience in Oncology
- Previous line management experience with team building and people/organizational development skills
- Excellent interpersonal skills and can build positive relationships across the organization
- Can effect change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business
- Proven project management experience, attention to detail with delegation and prioritisation skills
- Excellent organizational, analytical, influencing and resolution skills
- Excellent presentation and communication skills, verbal and written in English
- Excellent decision-making skills
- Excellent resource management skills and proven experience with budget management
- Good ability to learn and to adapt to work with IT systems.
- Ability for national and international travel
Desirable for the role
- Deep understanding of the Clinical Study Process, Procedural Documents and international ICH-GCP guidelines and related guidelines
- Excellent knowledge of the Monitoring Process, Study Drug Handling Process and the Data Management Process
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time
- Enjoy work in an environment of remote collaborators
- Integrity and high ethical standards
- Good conflict resolution skills and able to handle crisis
- Good interviewing skills – responsibility for attracting, developing and retaining personnel
- Good inter-cultural awareness
- Excellent ability to work according to global standards
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re open to trying new things at work, pioneering cutting edge methods and bringing teams together.
Great People want to Work with us! Find out why:
- GTAA Top Employer Award for 6 years:https://reviews.canadastop100.com/top-employer-astrazeneca-canada
- Best Workplace Culture Award at the 2018 Canadian HR Awards:https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/
- Learn more about our culture:https://www.linkedin.com/posts/genarestivo_greatpeople-greatplacetowork-topemployers2020-activity-6608742174811049985-N-8G
Are you ready to bring new insights and forward-thinking to the table? We have one seat available, and we hope it’s yours!
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 authorisation and employment eligibility verification requirements.