Business Operations Manager (Global Site Monitoring)

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

We are currently searching for a Business Operations Manager (Global Site Monitoring) reporting into the Business Operations Lead, Clinical Operational Excellence. This role is a home-based position. Potential candidates must reside in the province of Ontario with a preference for the Greater Toronto and surrounding areas.

Purpose and Scope:

The Business Operations Manager position is responsible for the execution of assigned responsibilities within the relevant Clinical Operations support function for both early and late-stage Clinical Operations.

Support functions in scope for this position may include:

• Legal Operations - includes Site Budgets, Contracts and Payments
• Business Operations includes department performance management, metrics, and enhancement, departmental communication strategy & management
• Trial Master File
• Process, Training & Development
• Clinical Standards - includes the overall study operational and support model
• Clinical Systems standards and management
• Monitoring
• Clinical Compliance
• Vendor Strategy & Management

This role is also accountable for the management of budgets, timelines, and workload

Essential Job Duties

• Contribute to the development of training process and materials to support monitoring execution
• Contribute to the development of workflows and templates in CTMS to support monitoring process
• Contribute to the development of monitoring visit report language and other monitoring activity documentation
• Leverage current Risk Based Quality Management approaches, knowledge of Good Clinical Practices and monitoring experience to collaborate on the development of the internal site monitoring capability
• Draft or assist in drafting procedural language to direct monitoring activities
• Provide subject matter expertise to the development of procedures, workflows, tools, and templates to support site monitoring capability.

Facilitate training of monitors regardless of resourcing model

• Work with outsourced providers to ensure training is fit for purpose and assist in addressing unique training needs
• Potential for delivering direct training to CRAs if internally resourced
• Identify supplementary training needs as monitoring delivery is implemented

Provide oversight of monitoring activities

• Potential to evolve into site monitor line management role if skillset and interest warrants
• Contribute to the development of metrics and dashboards to oversee monitoring and ensure quality execution
• Work with Business Strategy Lead to address deficiencies identified through oversight activities
• Potential to perform monitoring oversight including metrics review, qualitative assessments and oversight visits
• Contribute to the development of site monitoring oversight process

Cross-functional responsibilities:

• Collaborate with external departments (Data Science, QA) where it impacts site monitoring strategy and tools
• Liaise with Clinical Operations Leads and Clinical Trial Leads to ensure site monitoring is effectively managing site risk and to obtain performance feedback

Required Qualifications

• Minimal (10-15%) travel required
• Familiarity with and commitment to RBQM approaches.
• BA/BS with at least 5 years recent experience in site monitoring and/or management.
• Excellent written/oral communication skills as well as strong organizational and multi-tasking skills
• Fluent in English.
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.

Preferred Qualifications

• Experience in working cross functionally and with external providers
• Experience with development and implementation of process improvement related initiatives

Additional Information

Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.

Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation. An individual is considered to be “fully vaccinated” two weeks or more after the receipt of the second dose in a two-dose Vaccine or one dose of a single-dose Vaccine, or if the individual is otherwise considered to be Fully Vaccinated by the government of the province in which they are employed. If booster shots are required by a relevant Canadian public health authority (with requirements varying potentially based on the Vaccine), “fully vaccinated” should be interpreted to mean fully compliant with any such recommendations within a reasonable amount of time-based on the accessibility and availability of the booster shots.

Application Procedure

If your skills and experience match our needs, please email your resume to: [email protected].

Please indicate position applied to in your application.

No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted.