Senior Global Study Leader, Biopharmaceuticals
At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make a significant difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.
Our purpose is bold and so is our approach. Becoming a more agile and innovative company means building a vibrant, inspiring culture where we celebrate entrepreneurial thinking and act with a sense of urgency. We are courageous, taking risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of succeeding. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to achieve our goal to create and deliver medicines.
Position Title: Senior Global Study Leader, Biopharmaceuticals
Position Type: 12 month Contract
Location: Mississauga, Head Office
Career Level: F
The Senior Global Study Leader (SGSL) is a business-critical role within Study Management Late, Biopharmaceuticals whose main accountability is the operational planning and delivery of high priority and complex clinical studies within a program, or across programs that are deemed most critical to the business.
As a SGSL, you are responsible for leading a cross-functional study team (core and extended) and for providing the team with direction and guidance to enable successful study delivery.
You may provide input to early study planning activities based on operational expertise and are accountable for the delivery of studies by ensuring an effective partnership and teamwork within the study team.
- Lead and coordinate a team of experts in accordance with STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of timelines, budget and quality standards
- Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight
- Assist the Director of Study Management with planning for upcoming clinical studies
- Collaborate with other functions to establish strategies and identify common practices aimed at increasing efficiency of global study teams
- Lead and facilitate communication across functions and provide guidance to study team members as needed
- For outsourced studies, be the primary AZ point of contact for the CRO Study Manager to ensure study delivery, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, following relevant AZ SOPs and guidelines (e.g. description of services and transfer of obligations)
- Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)
- Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities
- Develop and maintain relevant study plans including required input into study level quality and risk management planning with risk response strategies and clear issue resolution pathways
- Oversee study level performance against agreed upon plans, timelines and key performance indicators (quality and operational) by using company tracking systems and project timelines, while communicating any risks to timelines and/or quality to CPT, along with proposed mitigations
- Identify and report quality issues that have occurred and collaborate with all functions as necessary to overcome barriers and achieve desired outcomes
- Oversee Trial Master File (TMF) completion including ensuring the TMF plan and Expected Document List are in place and that QC activities are performed on an ongoing basis
- Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency)
- Responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for budget management through the study lifecycle
- Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines
- Support professional development of team by providing regular feedback on individual performance
- Provide guidance, training, expertise, mentoring and support to less experienced GSL colleagues
- Leads non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager
Education & Experience:
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
- Previous project management experience and training
- At least 7 years of clinical trial experience
- At least 3 years of experience in global study leadership and team leadership
- Demonstrated study management expertise/abilities e.g. in leading large phase 3 pivotal studies with a high degree of complexity, or smaller studies simultaneously
- Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery; start up, maintenance and close out
- Proven project management experience on a global level (APM or similar training)
- Advanced degree, Masters level education (or higher)
- Project management certification
- Formal therapeutic area training
- Experience in all phases of a clinical study lifecycle
Skills & Capabilities:
- Strong strategic and critical thinking abilities
- Proven skillset and abilities to solve complex problems and make strong decisions
- Strong abilities in establishing and maintaining effective working relationships with strong conflict management skills
- Demonstrated abilities in mentoring
- Excellent communication and interpersonal skills
- Ability to lead multiple challenging priorities
- Experience in external provider oversight and management
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 interested in working at AZ? Apply today!
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.