Director, Site Management – Monitoring

🔥 12 hours ago

🇨🇦 Canada – Remote

💵 $151.9k - $199.3k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 0%

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AstraZeneca

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-02

Healthcare • Biotechnology • Pharmaceuticals

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines. It primarily works in areas of oncology, cardiovascular, renal & metabolism, and respiratory diseases. With operations in over 100 countries, AstraZeneca is dedicated to scientific research and a commitment to providing effective treatments and improving patient health across a wide array of conditions.

📋 Description

• Deliver the committed part of all supervised clinical interventional studies according to resources, budget, timelines, AZ Procedural Documents, ICH-GCP, and local regulations • Line manage dedicated staff groups and plan and utilize staff resources and assigned budgets • Set objectives and follow up on performance • Contribute to regional and global work tasks as delegated • Ensure study sites are identified, qualified, set up, initiated, supervised, closed, and archived • Lead dedicated groups and build team spirit, team style, and behaviour • Ensure adequate study resources and appropriate workloads • Develop and performance-manage direct reports • Ensure direct reports have development and training plans • Coach direct reports and coordinate external coaching when needed • Prepare salary and bonus proposals for direct reports with leadership and HR • Contribute to efficient country-level SMM organization and functioning • Contribute to feasibility work and quality improvement of study processes • Supervise country-level study delivery targets for speed and quality • Keep all systems updated and ensure the eTMF remains inspection-ready • Assist with forecasting study timelines, resources, recruitment, materials, and drugs • Direct LSAD/Local Study Teams on major study commitments and resolve key issues • Support regional SMM initiatives and collaborate with Medical Affairs • Ensure study activities align with local policies and codes of ethics • Review SQV reports and accompanied/co-monitoring/training/QC visits • Perform accompanied site visits according to local QC plans

🎯 Requirements

• 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 • Ability to manage change with a positive approach • 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 therapeutic areas • Ability to deliver quality according to requested standards • Ability to identify and champion efficient and effective methods/processes for delivering quality clinical trials with reduced budget and time • Ability to learn and adapt to IT systems • Ability for national and international travel

🏖️ Benefits

• Annual Variable Pay Bonus/Short Term Incentive opportunity • Eligibility to participate in equity-based long-term incentive program (if applicable to role) • Competitive Flex Benefits & Retirement Savings Program • 4 weeks’ paid vacation • Annual Personal Days • Contract Benefits Program for Fixed Term Contract/Temporary positions (excluding students) • Accommodation available on request for persons with disabilities • Diversity and inclusion commitment • AI used as part of the recruitment process