Global Study Associate Director, Respiratory and
2 weeks ago
**Global Study Associate Director, Respiratory and Immunology**
**Hybrid Work
- 3 days/week from our Mississauga office**
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
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.
**Summary**
The Global Study Associate Director (GSAD) is responsible for leading a cross-functional study team (core and extended) and providing them with guidance to enable successful study delivery. You are the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. The GSAD is accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.
**What you’ll do**:
- Lead, provide guidance, and delegate appropriately to a cross-functional study team or supervise outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and/or oversight of several studies.
- Lead and facilitate communication across all functions, including external partners and service providers. Lead and conduct investigator meetings and other study related meetings.
- Provide input and hold accountability for the development of study level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR))
- Ensure all external service providers (i.e., Contract Research Organizations (CROs), central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.
- Develop and maintain relevant study plans including required input into study level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
- Accountable for ensuring that information in all systems applied at a study-level (e.g. ACCORD/ABACUS, PharmaCM, etc.) are current and accurate.
- Measure study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines. Communicate any risks to timelines and/or quality to CPT and sDSM/DSM along with proposed mitigations
- Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary
- Proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.)
- Supervise Trial Master File (TMF) completion, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness
- Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, financial system attestations, Clinical Trial Transparency)
- Responsible for study budget re-forecasting and accountable for budget management through the study lifecycle. Providing budget progress reports including any financial risks and mitigation plans (as part of the ongoing study change control process)
- Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines; GSAD is the primary Study Management point-of-contact in the event of an audit or inspection
- Provide regular feedback on individual performance to team members and their line managers to support their professional development; may mentor less experienced colleagues
- Work on non-drug project work such as being a Study Management representative in process improvements and/or leading improvement projects as discussed
-
Global Study Manager
1 month ago
Mississauga, Canada AstraZeneca Full time**Short role description**: The Global Study Manager is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report...
-
Mississauga, ON, Canada AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...
-
Mississauga, Canada AstraZeneca Full timeDo you have leadership skills and an in depth knowledge within Regulatory Affairs? Do you want to work on innovative projects of importance for our early Respiratory and Immunology portfolio? At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and truly transform patient outcomes. This means our people are here to win, we...
-
Mississauga, Canada AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...
-
Mississauga, Canada AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...
-
Mississauga, Canada AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...
-
Mississauga, ON, Canada AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...
-
Senior Global Development Scientist Director
4 weeks ago
Mississauga, Canada AstraZeneca Full timeJob Title: Senior Global Development Scientist Director Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clinical input to all aspects of late stage product development. This includes but is not...
-
Senior Global Development Scientist Director
4 weeks ago
Mississauga, Canada AstraZeneca Full timeJob Title: Senior Global Development Scientist Director Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clinical input to all aspects of late stage product development. This includes but is not...
-
Senior Global Development Scientist Director
1 month ago
Mississauga, Canada AstraZeneca Full timeJob Title: Senior Global Development Scientist Director Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clinical input to all aspects of late stage product development. This includes...
-
Senior Global Development Scientist Director
3 weeks ago
Mississauga, Canada AstraZeneca Full timeJob Title: Senior Global Development Scientist Director Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clinical input to all aspects of late stage product development. This includes but is not...
-
Senior Global Development Scientist Director
3 weeks ago
Mississauga, ON, Canada AstraZeneca Full timeJob Title: Senior Global Development Scientist Director Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clinical input to all aspects of late stage product development. This includes but is...
-
Global Study Associate
1 month ago
Mississauga, Canada AstraZeneca Full time**Global Study Associate, Oncology (12 Month Contract)** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized...
-
Global Study Associate
1 month ago
Mississauga, Canada AstraZeneca Full timeAt AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing...
-
Clinical Study Associate-
1 month ago
Mississauga, Canada GSK Full time**Site Name**: Canada - Ontario - Mississauga **Posted Date**: Apr 24 2024 **_ Are you someone who is passionate and interested in a career at the pharmaceutical industry? Are you interested in clinical trials and how they make an impact on patient lives? If so, this internship with GlaxoSmithKline may be the right opportunity for you!_** **Job...
-
IL-5 Medical Lead, Respiratory
3 weeks ago
Mississauga, Canada 837 GlaxoSmithKline Inc. Full timeJob Purpose: The Medical Lead within Medical Affairs will be responsible for providing expert scientific capability and leadership while being accountable for a broad range of Medical Affairs activities associated with assigned products and within the Respiratory Therapeutic Area. The Medical Lead within Medical Affairs will be responsible for: Leading...
-
Global Study Manager, Haematology
1 week ago
Mississauga, Canada AstraZeneca Full timeGlobal Study Manager, Haematology (CAR-T Program) 12 Month Contract Hybrid Work- 3 days/week from Mississauga office At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and...
-
Associate Director, Global Patient Safety
4 weeks ago
Mississauga, Canada AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...
-
Associate Director, Strategic Feasibility
1 month ago
Mississauga, Canada AstraZeneca Full timeThe **Associate Director Strategic Feasibility (ADSF)** role is TA aligned to ensure close partnership with the TA organisations for design and delivery of the portfolio, and to support growing therapeutic knowledge balanced with data analytics/interpretation and technical skills. And a good understanding of global, regional and local country landscape and...
-
Study Delivery Associate
1 month ago
Mississauga, Canada AstraZeneca Full time**Study Delivery Associate (12 Month Contract)** **Hybrid Work - 3 days a week from our Mississauga, Canada office** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the...
