Director, Site Management & Monitoring

AstraZeneca; Mississauga; On-site; CAD 152,000 - 199,000; Full time

Job summary

AstraZeneca Canada seeks a Director Site Management & Monitoring to lead dedicated teams and ensure delivery of interventional studies compliant with ICH-GCP and AZ procedures while managing budgets and timelines. The role may involve regional responsibilities and collaboration with local Medical Affairs and Clinical Operations.

Essential: degree in life sciences, 5+ years in Development Operations, strong leadership, and regulatory knowledge.

Qualifications

• Bachelor degree in related subject area, preferably in life science, or equivalent qualification.
• Proficiency in French (if in Quebec).
• Minimum 5 years of experience in Development Operations (CRA / SrCRA / LSAD) or other related fields.
• Excellent interpersonal skills.
• Proven project management experience.
• Ability to travel nationally and internationally.
• Ability to lead and develop staff.
• Strong knowledge of the Clinical Study Process and ICH-GCP guidelines.

Responsibilities

• Provide leadership to dedicated group, building team spirit and performance.
• Ensure adequate resources and manage workload for studies assigned.
• Develop and appraise direct reports; set development plans.
• Coach staff regularly and arrange external coaching if needed.
• Prepare salary and bonus proposals in collaboration with senior leadership.
• Contribute to regional/global SMM tasks and country-level operations.
• Support high-quality feasibility work and timely study delivery.
• Ensure study processes, quality improvements, and documentation readiness (eTMF).

Skills

Interpersonal skills

Project management

Leadership

Communication (oral & written)

ICH-GCP knowledge

Budgeting & resource planning

Travel readiness

Change management

French language

Education

Bachelor degree in life sciences or related

Job description

Title: Director, Site Management & Monitoring

Location: Field (Ontario Preferred)

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 Director Site Management & Monitoring (DSMM) is accountable for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. The DSMM is responsible for line managing dedicated group(s) of staff and responsible for planning and utilization of staff resources, assigned budget, objective setting and performance follow-up. It is also expected that the DSMM may contribute to regional/global work tasks as delegated. As assigned, the DSMM is accountable for ensuring that study sites are identified, site qualifications performed, set up, initiated, supervised, closed and documentation archived. In some countries a DSMM may also take ownerships as Local Study Associate Director (LSAD) or Clinical Quality Associate Director (CQAD) if required and agreed with the (Senior) Director, Country Head.

Typical Accountabilities:

• Leadership of dedicated group, building the team spirit, developing team style and behaviour.
• Ensures adequate resources for the studies assigned.
• Ensures that the workload of direct reports is adequate.
• Development and performance management of direct reports.
• Ensures that direct reports have development and training plans, according to IDP process.
• Coaches the direct reports on a regular basis, and plans/organises coaching with external providers if needed.
• Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible (Senior) Director, Country Head and local HRBP.
• Contributes to efficient SMM organisation and its functioning at country level by working closely with responsible (Senior) Director, Country Head.
• Contributes to high quality feasibility work.
• Supervises successful delivery of SMM study delivery country level targets to plan, with speed and quality.
• Contributes to the quality improvement of the study processes and other procedures.
• Ensures all systems are continuously updated.
• Ensures completeness and timeliness of the eTMF to maintain it "Inspection Ready".
• Assists (Senior) Director, Country Head or Local Study ADs/ Local Study Teams in forecasting study timelines, resources, recruitment, study materials and drugs.
• Provides direction to LSAD/ Local Study Teams on major study commitments including resolving any key issues identified.
• Supports SMM region in initiatives/activities as agreed with (Senior) Director, Country Head.
• Ensures collaboration with local Medical Affairs team.
• Ensures that study activities at country level align with local policies and code of ethics.
• Reviews SQV reports of direct reports in line with AZ SOPs
• Reviews Accompanied site visits/co- monitoring visits/training visits/QC visits performed to direct reports in line with the local QC plans.
• Performs accompanied site visits according to local QC Plan, supporting ongoing coaching and development.

Education, Qualifications, Skills and Experience:

Essential

• Bachelor degree in related subject area, preferably in life science, or equivalent qualification (*)
• Proficiency in both spoken and written french is a requirement (If in Quebec)
• Minimum 5 years of experience in Development Operations (CRA / SrCRA / LSAD) or other related fields.
• Excellent interpersonal skills.
• Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and contribute to business.
• Proven project management experience.
• Excellent organisational, analytical, influencing and negotiation skills.
• Excellent presentation and communication skills, verbal and written.
• Line management experience.
• Very good knowledge of the Clinical Study Process and international ICH-GCP guidelines.
• Excellent knowledge of the Monitoring Process.
• Good understanding of the Study Drug Handling Process and the Data Management Process.
• Good knowledge of relevant local and international regulations.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• Ability to deliver quality according to the requested standards.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Good ability to learn and to adapt to work with IT systems.
• Ability for national and international travel.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canada's Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [e-mail].

Annual base salary for this position ranges from 151,884.00 to 199,347.75.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks' paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.