Study Start-up Manager, Oncology

2 weeks ago

Mississauga, Ontario, Canada AstraZeneca Full time

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.


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.


The Oncology Study Start-Up Manager (Onc SSU Manager) has local responsibility for the delivery of site start up activities for assigned studies and are active participants in the study team(s).

The Onc SSU Manager works in close collaboration with Monitors, Support Services, Research sites, Local Health Authorities and Ethics Committees and the Local Study Delivery Team to ensure that quality and quantity of site activation deliverables are achieved in a timely and efficient manner.


The Onc SSU Manager is responsible for ensuring that all requirements for site activation are in place for the agreed number of centres in clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations.

Deliver according to the commitment in the individual trials and local site activation process.


An Onc SSU Manager with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Site Activation Team Leader (SATL), as appropriate locally.


Responsibilities:

  • Follow up on intermediate letters, questions and answers, authorization
  • Filing of documents on AZ filing system, with support of CSA
  • Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents.
  • Assist in coordination and administration of clinical studies from startup through site activation.
  • Actively participate in local Study Delivery Team meetings and work cross functionally with Contracts, Feasibility and Study Support Services in SM&M.
  • Activate study sites in compliance with AZ Procedural Documents.
  • Share information (metrics) on study site progress towards activation within local Study Delivery Team and SM&M leadership as required.
  • Drive delivery of regulatory documents at the sites. Proactively ensure submission and activation against effective planned timelines defined with the LST, and identify delays in startup activities and the risks to the activation plan.
  • Primary reviewer of site level Informed Consent Forms, as locally appropriate
  • Update Veeva Clinical Vault (VCV) and other systems with data from centres as per required per SAT process, as locally appropriate.
  • Ensure regulatory binders and study supplies are provided for study site start up and/or delivered as per SAT process and agreement with Local Study Delivery Team.
  • Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.
  • Ensure compliance with AstraZeneca's Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
  • Ensure completeness of the Study Master File for study startup documents and site activation
- and ensure essential documents are filed in the TMF enterprise system (Veeva).

  • Ensure timely delivery of proper documents for support of study team submission to Regulatory Authorities.
  • Ensure that all start up study documents are ready for final archiving and signoff completion of local part of the Trial Master File.
  • Contribute to the production of study start up documents, ensuring template and version compliance.
  • Create and/or import clinicalregulatory documents into the A New Global Electronic Library (ANGEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in ANGEL.
  • Setup, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. Veeva, MS Teams, Box etc) and support others in the usage of these systems.

Additional Responsibilities:

  • Contribute to process improvements, knowledge transfer and best practice sharing.
  • Proactively share applicable information that may be relevant to other functions

Great People want to Work with us Find out why:

  • GTAA Top Employer Award for 9 years
  • Learn about our culture
  • Learn more about working with us in Canada
  • View our YouTube channel


AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve.

In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions

  • Global Study Manager

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    Location: Mississauga office (Hybrid 3 days in 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...

  • Associate Director Study Data Manager

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    Job Title: Associate Director Study Data ManagerCareer Level - EIntroduction to Role:Join our team as an Associate Director Study Data Manager, where you will be tasked with coordinating Clinical Data Management (CDM) deliverables for assigned clinical studies. As a member of the Global Study Team (GST), you will act as the primary point of contact for the...

  • Product Manager, Oncology

    2 weeks ago

    Mississauga, Ontario, Canada Ipsen Biopharmaceuticals Canada Inc. Full time

    Genericization, New Product launch and Growth Molecules. If these terms captured your attention, then I have the perfect Product Manager role for you.As our Oncology Product Manager, you will develop strategies and tactics for oncology products. Specific areas of focus include brand plan development and implementation, target customer identification and...

  • Project Manager, Oncology Program

    2 weeks ago

    Mississauga, Ontario, Canada Trillium Health Partners Full time

    Job Description:PROJECT MANAGER | ONCOLOGY | NON-UNION POSITIONPosition: Project Manager, Oncology ProgramFile#:Status:Full Time (x1)Wage: $ $48.32 (PG 10)Dept: Regional Cancer ProgramSite:Credit Valley HospitalHours/Shifts:Monday to Friday | Day Shift | 37.5 hours a weekPosted:March 7th, 2023Internal Deadline:March 28th, 2023***Trillium Health Partners...

  • Forecasting Leader, Oncology

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    Join the fastest growing team determined to change the practice of medicine and change the way we view cancer. Here we are removing the fear by eliminating cancer as a cause of death.We relentlessly follow the science - purposefully pushing back the limits of knowledge. From pioneering innovative treatment pathways, to shaping the care environment and...

  • Key Account Manager, Oncology- Ontario

    2 weeks ago

    Mississauga, Ontario, Canada Merck KGaA Darmstadt Germany Full time

    Work Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

  • Global Study Manager, Haematology

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    Global 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 knowledgesharing, ambitious thinking and innovation ultimately providing employees with the opportunity to work across teams, functions and even the...

  • Key Account Manager, Oncology

    2 weeks ago

    Mississauga, Ontario, Canada Merck KGaA Darmstadt Germany Full time

    Work Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

  • Senior Medical Director – Hematology Early Oncology R&D

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. We are more than one of the world's leading pharmaceutical companies. AstraZeneca has a multifaceted environment that cultivates collaboration...

  • Senior Statistical Programmer, Oncology

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    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...

  • Director of Translational Medicine Oncology Drug

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    Director of Translational Medicine Oncology Drug Project ManagementLocation: Gaithersburg, MD and Waltham, MAThe TM Oncology Drug Project Management group within Translational Medicine Oncology is accountable for providing project and portfolio management to the AZ TM Oncology portfolio to ensure successful delivery of Translational projects from initiation...

  • Analytics Leader, Oncology

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    The Oncology therapy area at AstraZeneca is unparalleled. We have built and strategically acquired one of the most promising Oncology pipelines in the industry. You will be among inspiring oncology industry leaders who will keep you engaged and empower you to be the best. We seek out opportunities to do dynamic meaningful work which means we won't just...

  • Senior Study Manager

    2 weeks ago

    Mississauga, Ontario, Canada Lycopodium Full time

    With offices in Australia, Canada, Africa. Peru and the Philippines, Lycopodium proudly delivers high quality professional engineering and project delivery services globally, across the resources, infrastructure and industrial processes sectors. By joining our global team and learning from renowned subject matter experts, we can offer you a diverse career...

  • Project Manager, Oncology R&D

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    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...

  • Administrative Coordinator, Oncology R&d

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    Administrative Coordinator, Oncology R&D**Mississauga, Canada (hybrid work- an average of 3 days/week in 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...

  • Oncology R&d Communication Projects and Events

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    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...

  • Program Management Director, Oncology R&D

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    Director Program Management, Oncology R&D (ORD) Hybrid Work- on average 3 days per week Minimum 1 day from Mississauga office 2 days from Mississauga or Downtown office Join us at AstraZeneca where we value a collaborative culture that encourages knowledge-sharing.

  • Regulatory Affairs Manager, Oncology

    2 weeks ago

    Mississauga, Ontario, Canada GSK Full time

    Site Name: Mississauga Milverton DrivePosted Date: May Key Accountabilities/Responsibilities: Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization area Accountable for a portfolio of products, specific in the Oncology therapy area, including the preparation, filing and...

  • Oncology Training

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    This is a contract role until Jan 31st, 2025At 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...

  • Physiotherapist - 0A Oncology

    2 weeks ago

    Mississauga, Ontario, Canada Trillium Health Partners Full time

    Job Description NON-UNION Physiotherapist _________________________________________________________________________ Position: Physiotherapist - OA Oncology File#: Status: Temporary Part Time (approximately 8months) Wage: Allied Heatlh (AH10.4)$ $54.66 Dept/Health System: OA Oncology Site: Credit Valley Hospital Hours of Work/Shift:...